<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/NCT04419662</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-40-20</org_study_id>
    <secondary_id>2020-000573-25</secondary_id>
    <nct_id>NCT04419662</nct_id>
  </id_info>
  <brief_title>Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion &amp; Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures</brief_title>
  <official_title>Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion &amp; Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the influence of PEEP (Positive end-expiratory pressure), changes in preload&#xD;
      (patient position) and changes in afterload (phenylephrine) on ultrasound measures of renal&#xD;
      perfusion in patients after uncomplicated cardiac surgery.&#xD;
&#xD;
      To investigate the effects of phenylephrine on both invasive measures of the systemic- and&#xD;
      pulmonary circulation and, secondarily, to assess the induced changes in echocardiographic&#xD;
      indices of left- and right ventricular systolic- and diastolic function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Ultrasound analysis is performed offline and details on participants and time of measurement are blinded for the person doing the analysis. The personnel responsible for obtaining data will not be blinded towards any of the interventions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Renal arterial resistive index (RI).</measure>
    <time_frame>75 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)</measure>
    <time_frame>75 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal venous impedance index.</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal venous stasis index.</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Portal vein pulsatility fraction.</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transoesophageal measurement of left and right ventricular function 1</measure>
    <time_frame>75 minutes</time_frame>
    <description>Systolic measure (ejection fraction (EF))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transoesophageal measurement of left and right ventricular function 2</measure>
    <time_frame>75 minutes</time_frame>
    <description>Systolic measure (s')</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transoesophageal measurement of left and right ventricular function 3</measure>
    <time_frame>75 minutes</time_frame>
    <description>Systolic measure (strain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transoesophageal measurement of left and right ventricular function 4</measure>
    <time_frame>75 minutes</time_frame>
    <description>Diastolic measures (E, A,)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transoesophageal measurement of left and right ventricular function 5</measure>
    <time_frame>75 minutes</time_frame>
    <description>Diastolic measures (e', a')</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transoesophageal measurement of left and right ventricular function 6</measure>
    <time_frame>75 minutes</time_frame>
    <description>Diastolic measure (deceleration time)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Ultrasonography, Renal</condition>
  <condition>Cardiac Surgery</condition>
  <condition>Hemodynamics</condition>
  <condition>Phenylephrine</condition>
  <condition>Renal Perfusion</condition>
  <condition>Echocardiography</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>All patients included</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>Three time points: before, during and 20-30 minutes after infusion of phenylephrine.&#xD;
Patients will receive an infusion of up to 1 mcg/kg/min phenylephrine intravenously to raise mean arterial pressure with 20 mmHg for 10 minutes. Infusion of phenylephrine will start at 0.1 mcg/kg/min with subsequent titration to effect.</description>
    <arm_group_label>All patients included</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combination of PEEP and positioning</intervention_name>
    <description>Six time points based on combinations of the following:&#xD;
Three different levels of PEEP (as set on the ventilator): 0, 6 and 12 mmHg. Two different positions: 1) torso elevated 30 degrees, legs horizontal and 2) torso horizontal, legs elevated 30 degrees.</description>
    <arm_group_label>All patients included</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients ≥ 18 years scheduled for open elective cardiac surgery at the Department&#xD;
             of Cardiothoracic &amp; Vascular Surgery, Aarhus University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient ultrasonographic imaging of the kidneys&#xD;
&#xD;
          -  Known morphological kidney disease&#xD;
&#xD;
          -  Preoperative dialysis&#xD;
&#xD;
          -  Chronic atrial fibrillation&#xD;
&#xD;
          -  Planned mitral valve 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>Peter Juhl-Olsen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Johan F Hermansen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital, Department of Anaesthesiology</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Johan Fridolf Hermansen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04419662
org study id: 1-10-72-40-20
secondary id: 2020-000573-25
nct id: NCT04419662
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To investigate the influence of PEEP (Positive end-expiratory pressure), changes in preload
      (patient position) and changes in afterload (phenylephrine) on ultrasound measures of renal
      perfusion in patients after uncomplicated cardiac surgery.

      To investigate the effects of phenylephrine on both invasive measures of the systemic- and
      pulmonary circulation and, secondarily, to assess the induced changes in echocardiographic
      indices of left- and right ventricular systolic- and diastolic function.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
masking description: Ultrasound analysis is performed offline and details on participants and time of measurement are blinded for the person doing the analysis. The personnel responsible for obtaining data will not be blinded towards any of the interventions.
measure: Renal arterial resistive index (RI).
time frame: 75 minutes
measure: The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)
time frame: 75 minutes
measure: Renal venous impedance index.
time frame: 75 minutes
measure: Renal venous stasis index.
time frame: 75 minutes
measure: Portal vein pulsatility fraction.
time frame: 75 minutes
measure: Cardiac output
time frame: 75 minutes
measure: Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.
time frame: 75 minutes
measure: Transoesophageal measurement of left and right ventricular function 1
time frame: 75 minutes
description: Systolic measure (ejection fraction (EF))
measure: Transoesophageal measurement of left and right ventricular function 2
time frame: 75 minutes
description: Systolic measure (s')
measure: Transoesophageal measurement of left and right ventricular function 3
time frame: 75 minutes
description: Systolic measure (strain)
measure: Transoesophageal measurement of left and right ventricular function 4
time frame: 75 minutes
description: Diastolic measures (E, A,)
measure: Transoesophageal measurement of left and right ventricular function 5
time frame: 75 minutes
description: Diastolic measures (e', a')
measure: Transoesophageal measurement of left and right ventricular function 6
time frame: 75 minutes
description: Diastolic measure (deceleration time)
arm group label: All patients included
arm group type: Experimental
intervention type: Drug
intervention name: Phenylephrine
description: Three time points: before, during and 20-30 minutes after infusion of phenylephrine.
Patients will receive an infusion of up to 1 mcg/kg/min phenylephrine intravenously to raise mean arterial pressure with 20 mmHg for 10 minutes. Infusion of phenylephrine will start at 0.1 mcg/kg/min with subsequent titration to effect.
arm group label: All patients included
intervention type: Other
intervention name: Combination of PEEP and positioning
description: Six time points based on combinations of the following:
Three different levels of PEEP (as set on the ventilator): 0, 6 and 12 mmHg. Two different positions: 1) torso elevated 30 degrees, legs horizontal and 2) torso horizontal, legs elevated 30 degrees.
arm group label: All patients included
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Juhl-Olsen, MD, PhD
role: Study Chair
affiliation: Aarhus University Hospital
last name: Johan F Hermansen, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Johan Fridolf Hermansen
investigator title: Principal Investigator
mesh term: Phenylephrine
mesh term: Oxymetazoline
sharing ipd: No