xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009809</url>
    </required_header>
    <id_info>
      <org_study_id>4708</org_study_id>
      <nct_id>NCT06009809</nct_id>
    </id_info>
    <brief_title>Blood Velocity Variation in Right Renal and Superior Mesenteric Arteries During Cardio-pulmonary Bypass</brief_title>
    <official_title>Blood Velocity Variation in Right Renal and Superior Mesenteric Arteries During Cardio-pulmonary Bypass</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The cardiopulmonary by-pass technique, used in cardiac surgery to obtain a bloodless&#xD;
        operating field and an immobile heart, determines important effects on the blood vessel wall,&#xD;
        especially when a continuous and non-continuous blood flow is used. In fact, a reduction in&#xD;
        Nitric Oxide (NO) production by the endothelium, an increase in systemic vascular resistance&#xD;
        and an increased risk of cerebral and renal hypoperfusion have been observed and can result&#xD;
        in potential organ damage. Acute kidney injury (AKI) after heart surgery is a major cause of&#xD;
        mortality and morbidity. Its incidence varies according to different definitions, but can&#xD;
        reach 30%. In some series, 1-5% of patients require renal replacement therapy in the&#xD;
        postoperative period presenting a mortality that can reach 50-70%. However, even more limited&#xD;
        increases in serum creatinine are associated with worsening prognosis and the risk of chronic&#xD;
        kidney disease. The pathophysiology of AKI in cardiac surgery is complex and still partly&#xD;
        unknown.Recently a technique has been described that allows to measure the blood velocity in&#xD;
        the right renal artery and in the superior mesenteric artery using the transesophageal&#xD;
        echocardiogram (TEE); this technique allows to view these arteries and measure the speed of&#xD;
        the blood with good precision because the insonation angle (ie the angle formed by the&#xD;
        ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this&#xD;
        methodology allows you to monitor blood velocity in the right renal artery and superior&#xD;
        mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which&#xD;
        the blood velocity values in the renal arteries during cardiac surgery were used to calculate&#xD;
        the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. At&#xD;
        present, therefore, despite the fact that TEE is routinely used for monitoring renal&#xD;
        perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has&#xD;
        been little studied during cardiopulmonary by-pass (CPB) and has never been evaluated during&#xD;
        CPB with continuous flow; in particular, the possible variation in blood velocity measured&#xD;
        during CPB compared to the baseline values measured before extracorporeal circulation and its&#xD;
        correlation with the onset of postoperative renal failure is not known.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The cardiopulmonary by-pass (CPB) technique, used in cardiac surgery to obtain a bloodless&#xD;
        operating field and an immobile heart, determines important effects on the blood vessel wall,&#xD;
        especially when a continuous and non-continuous blood flow is used. In fact, a reduction in&#xD;
        NO production by the endothelium, an increase in systemic vascular resistance and an&#xD;
        increased risk of cerebral and renal hypoperfusion have been observed and can result in&#xD;
        potential organ damage.&#xD;
  &#xD;
        Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity.&#xD;
        Its incidence varies according to different definitions, but can reach 30%. In some series,&#xD;
        1-5% of patients require renal replacement therapy (RRT) in the postoperative period&#xD;
        presenting a mortality that can reach 50-70%. However, even more limited increases in serum&#xD;
        creatinine (sCr) are associated with worsening prognosis and the risk of chronic kidney&#xD;
        disease (CKD). The pathophysiology of AKI in cardiac surgery is complex and still partly&#xD;
        unknown. It is believed that one of the main causative factors is hypoperfusion and renal&#xD;
        hypoxia, in particular of the medullary region; this would result in a vasoconstriction of&#xD;
        the afferent arterioles to the glomerulus and a reduction in filtration. Risk factors&#xD;
        associated with the increased incidence of AKI include bleeding, use of the aortic pump,&#xD;
        excessive cardiopulmonary bypass duration, excessive haemodilution, insufficient pump flow,&#xD;
        or insufficient blood pressure. Hypothermia, which also has a protective effect against&#xD;
        hypoperfusion and tissue hypoxia, could induce AKI by increasing renal vascular resistance&#xD;
        and favoring medullary hypoxia during subsequent rewarming.&#xD;
  &#xD;
        In addition to AKI, another complication of cardiac surgery, rarer but associated with a&#xD;
        higher mortality, is acute mesenteric ischemia; the most frequent type is non-occlusive&#xD;
        mesenteric ischemia (NOMI) which seems to have as a predisposing cause a reduction or&#xD;
        maldistribution of splanchnic blood flow and the use of vasoconstrictors.&#xD;
  &#xD;
        Recently a technique has been described that allows to measure the blood velocity in the&#xD;
        right renal artery and in the superior mesenteric artery using the transesophageal&#xD;
        echocardiogram (TEE); this technique allows to view these arteries and measure the speed of&#xD;
        the blood with good precision because the insonation angle (ie the angle formed by the&#xD;
        ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this&#xD;
        methodology allows you to monitor blood velocity in the right renal artery and superior&#xD;
        mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which&#xD;
        the blood velocity values in the renal arteries during cardiac surgery were used to calculate&#xD;
        the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. The&#xD;
        calculation of these indices, however, requires the use of a pulsatile blood flow to generate&#xD;
        a periodic variation of the blood velocity, and they are not evaluable during CPB since the&#xD;
        current practice in almost all centers is to use a continuous blood flow. At present,&#xD;
        therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during&#xD;
        cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little&#xD;
        studied during CPB and has never been evaluated during CPB with continuous flow; in&#xD;
        particular, the possible variation in blood velocity measured during CPB compared to the&#xD;
        baseline values measured before extracorporeal circulation and its correlation with the onset&#xD;
        of postoperative renal failure is not known.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 15, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe</time_frame>
      <description>Right renal artery mean blood velocity (cm/sec) before CPB</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability</time_frame>
      <description>Right renal artery mean blood velocity (cm/sec) before CPB</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia</time_frame>
      <description>Right renal artery mean blood velocity (cm/sec) during CPB</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Right renal artery mean blood velocity (cm/sec) during CPB</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Right renal artery mean blood velocity (cm/sec) during CPB</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe</time_frame>
      <description>Superior mesenteric artery mean blood velocity (cm/sec) before CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability</time_frame>
      <description>Superior mesenteric artery mean blood velocity (cm/sec) before CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia</time_frame>
      <description>Superior mesenteric artery mean blood velocity (cm/sec) during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Superior mesenteric artery mean blood velocity (cm/sec) during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)</measure>
      <time_frame>CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Superior mesenteric artery mean blood velocity (cm/sec) during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between mean blood velocity values and hemodynamic parameters: cardiopulmonary by-pass (CPB) blood flow</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between mean blood velocity values and CPB blood flow</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and CPB blood flow</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and cardiopulmonary by-pass (CPB) blood flow</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia, during cardiopulmonary by-pass</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and MAP</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and MAP (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and MAP</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right arterial mean blood velocity (cm/sec) and mean arterial pressure (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and MAP</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and MAP</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and arterial PCO2</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and arterial PCO2</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean mean blood velocity values and laboratory parameters (Hematocrit)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and Temperature</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and Temperature</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and Temperature</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and Temperature</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and Temperature</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and Temperature</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees9</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and negative pressure applied to the venous drainage (vacuum-assist venous drainage) (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)</measure>
      <time_frame>CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity values and VAVD (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)</measure>
      <time_frame>CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)</measure>
      <time_frame>CPB 30 min: 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)</measure>
      <time_frame>CPB 60 min: 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)</measure>
      <time_frame>CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)</measure>
      <time_frame>CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)</measure>
      <time_frame>CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)</measure>
      <time_frame>CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia</time_frame>
      <description>Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according Kidney Disease Improving Global Outcomes (KDIGO) definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)</measure>
      <time_frame>CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia</time_frame>
      <description>Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)</measure>
      <time_frame>CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia</time_frame>
      <description>Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of serum Cystatin C in low right renal artery mean blood velocity during CPB</measure>
      <time_frame>Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass</time_frame>
      <description>Comparison between serum Cystatin C mean level (mg/L) measured in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) measured during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in low right renal artery mean blood velocity</measure>
      <time_frame>Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass</time_frame>
      <description>Comparison between urinary uNGAL mean level (ng/ml) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in low right renal artery mean blood velocity</measure>
      <time_frame>Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass</time_frame>
      <description>Comparison between urinary uNGAL mean level (ng/ml) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of lactate in patients with low superior mesenteric artery mean blood velocity values</measure>
      <time_frame>Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass</time_frame>
      <description>Comparison between mean arterial lactate (mmol/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of lactate in patients with low superior mesenteric artery mean blood velocity</measure>
      <time_frame>Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass</time_frame>
      <description>Comparison between arterial lactate (mmol/L) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery mean blood velocity (cm/sec) measured during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of amylase in low superior mesenteric artery mean blood velocity</measure>
      <time_frame>Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass</time_frame>
      <description>Comparison between mean serum amylase (UI/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) measured during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of amylase in low superior mesenteric artery mean blood velocity</measure>
      <time_frame>Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass</time_frame>
      <description>Comparison between mean serum amylase (UI/L) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) measured during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of measurement of right renal artery blood velocity during CPB</measure>
      <time_frame>During CPB</time_frame>
      <description>the number of patients in whom is possible to measure right renal artery blood velocity during CPB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of measurement of superior mesenteric artery blood velocity during CPB</measure>
      <time_frame>During CPB</time_frame>
      <description>the number of patients in whom is possible to measure superior mesenteric artery blood velocity during CPB</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">92</enrollment>
    <condition>Heart Surgical Procedure</condition>
    <arm_group>
      <arm_group_label>Heart Surgical Patients</arm_group_label>
      <description>Patients with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>transesophageal echocardiogram</intervention_name>
      <description>To measure mean blood velocity at the level of the right renal and superior mesenteric artery</description>
      <arm_group_label>Heart Surgical Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will enroll patients of both sexes, aged&gt; 18 years, with cardiovascular disease,&#xD;
          who must undergo cardiac surgery in extracorporeal circulation with continuous flow&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age&gt; 18 years&#xD;
  &#xD;
            -  written informed consent&#xD;
  &#xD;
            -  cardiac surgery with cardiopulmonary bypass (CPB)&#xD;
  &#xD;
            -  New York Heart Association (NYHA) class I, II, III&#xD;
  &#xD;
            -  preoperative serum creatinine less than 1.2 mg / dl&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  contraindications to Trans Esophageal Ultrasound (TEE) based on American Society of&#xD;
               Anesthesiologists (ASA) recommendations (esophageal or gastric diseases or previous&#xD;
               surgery)&#xD;
  &#xD;
            -  history of non-coronary arterial pathologies&#xD;
  &#xD;
            -  atrial fibrillation&#xD;
  &#xD;
            -  preoperative serum creatinine greater than 1.2 mg / dl • NYHA class IV&#xD;
  &#xD;
            -  emergency cardiac surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cavaliere Franco, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Fondazione Policlinico Agostino Gemelli IRRCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gabriella Arlotta, M.D.</last_name>
      <phone>+390630154848</phone>
      <email>g.arlotta72@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Temistocle Taccheri, M.D.</last_name>
      <phone>+390630154848</phone>
      <email>taccheri.temistocle@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fondazione Policlinico Universitario A,Gemelli IRCCS</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gabriella Arlotta, MD</last_name>
        <phone>+390630154848</phone>
        <email>gabriella.arlotta@policlinicogemelli.it</email>
      </contact>
      <contact_backup>
        <last_name>Temistocle Taccheri</last_name>
        <phone>+390630154848</phone>
        <email>temistocle.taccheri@policlinicogemelli.it</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 26, 2022</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>Dr.ssa Gabriella Arlotta</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>cardiopulmonary by-pass</keyword>
    <keyword>transesophageal echocardiogram</keyword>
    <keyword>acute kidney injury</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009809
  org study id: 4708
  nct id: NCT06009809
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The cardiopulmonary by-pass technique, used in cardiac surgery to obtain a bloodless
        operating field and an immobile heart, determines important effects on the blood vessel wall,
        especially when a continuous and non-continuous blood flow is used. In fact, a reduction in
        Nitric Oxide (NO) production by the endothelium, an increase in systemic vascular resistance
        and an increased risk of cerebral and renal hypoperfusion have been observed and can result
        in potential organ damage. Acute kidney injury (AKI) after heart surgery is a major cause of
        mortality and morbidity. Its incidence varies according to different definitions, but can
        reach 30%. In some series, 1-5% of patients require renal replacement therapy in the
        postoperative period presenting a mortality that can reach 50-70%. However, even more limited
        increases in serum creatinine are associated with worsening prognosis and the risk of chronic
        kidney disease. The pathophysiology of AKI in cardiac surgery is complex and still partly
        unknown.Recently a technique has been described that allows to measure the blood velocity in
        the right renal artery and in the superior mesenteric artery using the transesophageal
        echocardiogram (TEE); this technique allows to view these arteries and measure the speed of
        the blood with good precision because the insonation angle (ie the angle formed by the
        ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this
        methodology allows you to monitor blood velocity in the right renal artery and superior
        mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which
        the blood velocity values in the renal arteries during cardiac surgery were used to calculate
        the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. At
        present, therefore, despite the fact that TEE is routinely used for monitoring renal
        perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has
        been little studied during cardiopulmonary by-pass (CPB) and has never been evaluated during
        CPB with continuous flow; in particular, the possible variation in blood velocity measured
        during CPB compared to the baseline values measured before extracorporeal circulation and its
        correlation with the onset of postoperative renal failure is not known.
  The cardiopulmonary by-pass (CPB) technique, used in cardiac surgery to obtain a bloodless
        operating field and an immobile heart, determines important effects on the blood vessel wall,
        especially when a continuous and non-continuous blood flow is used. In fact, a reduction in
        NO production by the endothelium, an increase in systemic vascular resistance and an
        increased risk of cerebral and renal hypoperfusion have been observed and can result in
        potential organ damage.
  
        Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity.
        Its incidence varies according to different definitions, but can reach 30%. In some series,
        1-5% of patients require renal replacement therapy (RRT) in the postoperative period
        presenting a mortality that can reach 50-70%. However, even more limited increases in serum
        creatinine (sCr) are associated with worsening prognosis and the risk of chronic kidney
        disease (CKD). The pathophysiology of AKI in cardiac surgery is complex and still partly
        unknown. It is believed that one of the main causative factors is hypoperfusion and renal
        hypoxia, in particular of the medullary region; this would result in a vasoconstriction of
        the afferent arterioles to the glomerulus and a reduction in filtration. Risk factors
        associated with the increased incidence of AKI include bleeding, use of the aortic pump,
        excessive cardiopulmonary bypass duration, excessive haemodilution, insufficient pump flow,
        or insufficient blood pressure. Hypothermia, which also has a protective effect against
        hypoperfusion and tissue hypoxia, could induce AKI by increasing renal vascular resistance
        and favoring medullary hypoxia during subsequent rewarming.
  
        In addition to AKI, another complication of cardiac surgery, rarer but associated with a
        higher mortality, is acute mesenteric ischemia; the most frequent type is non-occlusive
        mesenteric ischemia (NOMI) which seems to have as a predisposing cause a reduction or
        maldistribution of splanchnic blood flow and the use of vasoconstrictors.
  
        Recently a technique has been described that allows to measure the blood velocity in the
        right renal artery and in the superior mesenteric artery using the transesophageal
        echocardiogram (TEE); this technique allows to view these arteries and measure the speed of
        the blood with good precision because the insonation angle (ie the angle formed by the
        ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this
        methodology allows you to monitor blood velocity in the right renal artery and superior
        mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which
        the blood velocity values in the renal arteries during cardiac surgery were used to calculate
        the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. The
        calculation of these indices, however, requires the use of a pulsatile blood flow to generate
        a periodic variation of the blood velocity, and they are not evaluable during CPB since the
        current practice in almost all centers is to use a continuous blood flow. At present,
        therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during
        cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little
        studied during CPB and has never been evaluated during CPB with continuous flow; in
        particular, the possible variation in blood velocity measured during CPB compared to the
        baseline values measured before extracorporeal circulation and its correlation with the onset
        of postoperative renal failure is not known.
  observational model: Cohort
  time perspective: Prospective
  measure: Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
  description: Right renal artery mean blood velocity (cm/sec) before CPB
  measure: Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
  description: Right renal artery mean blood velocity (cm/sec) before CPB
  measure: Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
  description: Right renal artery mean blood velocity (cm/sec) during CPB
  measure: Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
  description: Right renal artery mean blood velocity (cm/sec) during CPB
  measure: Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
  description: Right renal artery mean blood velocity (cm/sec) during CPB
  measure: Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
  description: Superior mesenteric artery mean blood velocity (cm/sec) before CPB
  measure: Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
  description: Superior mesenteric artery mean blood velocity (cm/sec) before CPB
  measure: Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
  description: Superior mesenteric artery mean blood velocity (cm/sec) during CPB
  measure: Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
  description: Superior mesenteric artery mean blood velocity (cm/sec) during CPB
  measure: Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
  time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
  description: Superior mesenteric artery mean blood velocity (cm/sec) during CPB
  measure: Correlation between mean blood velocity values and hemodynamic parameters: cardiopulmonary by-pass (CPB) blood flow
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
  measure: Correlation between mean blood velocity values and CPB blood flow
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
  measure: Correlation between right renal artery mean blood velocity values and CPB blood flow
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
  measure: Correlation between superior mesenteric artery mean blood velocity values and cardiopulmonary by-pass (CPB) blood flow
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
  measure: Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia, during cardiopulmonary by-pass
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
  measure: Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
  measure: Correlation between right renal artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and MAP
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and MAP (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and MAP
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between right arterial mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and MAP
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and MAP
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and arterial PCO2
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and arterial PCO2
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
  measure: Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
  measure: Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
  measure: Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
  measure: Correlation between superior mesenteric artery mean mean blood velocity values and laboratory parameters (Hematocrit)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
  measure: Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
  measure: Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
  measure: Correlation between right renal artery mean blood velocity values and Temperature
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
  measure: Correlation between right renal artery mean blood velocity values and Temperature
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
  measure: Correlation between right renal artery mean blood velocity values and Temperature
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
  measure: Correlation between superior mesenteric artery mean blood velocity values and Temperature
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
  measure: Correlation between superior mesenteric artery mean blood velocity values and Temperature
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
  measure: Correlation between superior mesenteric artery mean blood velocity values and Temperature
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees9
  measure: Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between right renal artery mean blood velocity (cm/sec) and negative pressure applied to the venous drainage (vacuum-assist venous drainage) (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
  time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)
  measure: Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity values and VAVD (mmHg)
  measure: Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)
  time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
  description: Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
  measure: Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)
  time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
  measure: Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)
  time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
  description: Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
  measure: Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)
  time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
  measure: Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)
  time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
  measure: Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)
  time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
  description: Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
  measure: Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)
  time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
  description: Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according Kidney Disease Improving Global Outcomes (KDIGO) definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
  measure: Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)
  time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
  description: Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
  measure: Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)
  time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
  description: Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
  measure: Evaluation of serum Cystatin C in low right renal artery mean blood velocity during CPB
  time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
  description: Comparison between serum Cystatin C mean level (mg/L) measured in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) measured during CPB
  measure: Evaluation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in low right renal artery mean blood velocity
  time frame: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
  description: Comparison between urinary uNGAL mean level (ng/ml) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) during CPB
  measure: Evaluation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in low right renal artery mean blood velocity
  time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
  description: Comparison between urinary uNGAL mean level (ng/ml) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) during CPB
  measure: Evaluation of lactate in patients with low superior mesenteric artery mean blood velocity values
  time frame: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
  description: Comparison between mean arterial lactate (mmol/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) during CPB
  measure: Evaluation of lactate in patients with low superior mesenteric artery mean blood velocity
  time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
  description: Comparison between arterial lactate (mmol/L) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery mean blood velocity (cm/sec) measured during CPB
  measure: Evaluation of amylase in low superior mesenteric artery mean blood velocity
  time frame: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
  description: Comparison between mean serum amylase (UI/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) measured during CPB
  measure: Evaluation of amylase in low superior mesenteric artery mean blood velocity
  time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
  description: Comparison between mean serum amylase (UI/L) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) measured during CPB
  measure: Feasibility of measurement of right renal artery blood velocity during CPB
  time frame: During CPB
  description: the number of patients in whom is possible to measure right renal artery blood velocity during CPB
  measure: Feasibility of measurement of superior mesenteric artery blood velocity during CPB
  time frame: During CPB
  description: the number of patients in whom is possible to measure superior mesenteric artery blood velocity during CPB
  arm group label: Heart Surgical Patients
  description: Patients with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow
  intervention type: Diagnostic Test
  intervention name: transesophageal echocardiogram
  description: To measure mean blood velocity at the level of the right renal and superior mesenteric artery
  arm group label: Heart Surgical Patients
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cavaliere Franco, M.D.
  role: Study Chair
  affiliation: Fondazione Policlinico Agostino Gemelli IRRCS
  last name: Gabriella Arlotta, M.D.
  phone: +390630154848
  email: g.arlotta72@gmail.com
  last name: Temistocle Taccheri, M.D.
  phone: +390630154848
  email: taccheri.temistocle@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: Dr.ssa Gabriella Arlotta
  investigator title: Principal Investigator