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/NCT06009445</url>
    </required_header>
    <id_info>
      <org_study_id>36264MS189/5/23</org_study_id>
      <nct_id>NCT06009445</nct_id>
    </id_info>
    <brief_title>Renal Resistive Index as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis</brief_title>
    <official_title>Renal Resistive Index by Renal Doppler Ultrasound as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis Patients: Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        We aim from this study to investigate the role of renal resistance index (RRI) in evaluation&#xD;
        of Acute kidney injury development and fluid administration in sepsis patients considering&#xD;
        the change in RRI values over 7 days from admission as a predictor of AKI development&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute kidney injury (AKI) is one of the most common problems in critically ill patients in&#xD;
        the clinic. AKI can be caused by various factors, such as hypovolemia, shock, major surgery,&#xD;
        trauma, and heart failure, of which sepsis is the most common&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 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>Prediction of AKI development by renal resistance index (RRI)</measure>
      <time_frame>7 days from admission</time_frame>
      <description>AKI was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.&#xD;
  The KDIGO guidelines define AKI as follows&#xD;
  Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or&#xD;
  Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or&#xD;
  Urine volume &lt;0.5 mL/kg/hour for six hours</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of fluid administration</measure>
      <time_frame>7 days from admission</time_frame>
      <description>RRI and other hypoperfusion markers after fluid challenge and divided into responder to fluid (Time 1 F) and non responder with noradrenaline administration (Time 1 N) .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of ICU stay</measure>
      <time_frame>2 months from admission till discharge</time_frame>
      <description>Length of ICU stay till discharge will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cumulative fluid balance over 7 days</measure>
      <time_frame>7 days from admission</time_frame>
      <description>Cumulative fluid balance over 7 days and urine output (intake -output) will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of 28 day mortality</measure>
      <time_frame>28 days from admission</time_frame>
      <description>The incidence of mortality will be measured at 28 day.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Renal Resistive Index</condition>
    <condition>Acute Kidney Injury</condition>
    <condition>Sepsis</condition>
    <arm_group>
      <arm_group_label>AKI group</arm_group_label>
      <description>Acute kidney injury (AKI) was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.&#xD;
  The KDIGO guidelines define AKI as follows:&#xD;
  Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or&#xD;
  Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or&#xD;
  Urine volume &lt;0.5 mL/kg/hour for six hours</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non AKI group</arm_group_label>
      <description>Patients who will no develop Acute kidney injury (AKI).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Renal resistive index</intervention_name>
      <description>The calculation formula for Renal resistive index (RRI) as follows :&#xD;
  (systolic peak flow velocity _ diastolic minimum flow velocity )/systolic peak flow velocity .&#xD;
  will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.&#xD;
  The median value of each section will be used and the 3 median values of each kidney will be averaged.</description>
      <arm_group_label>AKI group</arm_group_label>
      <arm_group_label>Non AKI group</arm_group_label>
      <other_name>Renal Doppler Ultrasound</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients admitted to Tanta university surgical intensive care unit (SICU)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age over 21 years&#xD;
  &#xD;
            -  meet Sepsis 3 criteria (potential source of infection , host response and organ&#xD;
               dysfunction) but not in septic shock.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients during pregnancy.&#xD;
  &#xD;
            -  patients with hepatorenal syndrome.&#xD;
  &#xD;
            -  Poor abdominal echogenicity eg.(morbid obesity ,increase intra abdominal pressure )&#xD;
  &#xD;
            -  Severe acute or chronic renal insufficiency .&#xD;
  &#xD;
            -  Dialysis dependency.&#xD;
  &#xD;
            -  Renal transplantation.&#xD;
  &#xD;
            -  Known renal artery stenosis.&#xD;
  &#xD;
            -  Mono-kidney, kidney tumor, anatomic kidney abnormalities.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Safinaz A Aboelfetoh, MBBCh</last_name>
      <role>Principal Investigator</role>
      <affiliation>Anesthesiology, Faculty of Medicine, Tanta University, Egypt.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Safinaz A Aboelfetoh, MBBCh</last_name>
      <phone>00201148855752</phone>
      <email>noralamar34@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tanta University Hospitals</name>
        <address>
          <city>Tanta</city>
          <state>Elgharbia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Safinaz A Aboelfetoh, MBBCh</last_name>
        <phone>00201148855752</phone>
        <email>noralamar34@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Ahmed M Hamed, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sameh M Sadek, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Aliaa M Belal, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 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>Tanta University</investigator_affiliation>
      <investigator_full_name>Safinaz Abdelkhalek Aboelfetoh</investigator_full_name>
      <investigator_title>Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>The data will be available after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06009445
  org study id: 36264MS189/5/23
  nct id: NCT06009445
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  We aim from this study to investigate the role of renal resistance index (RRI) in evaluation
        of Acute kidney injury development and fluid administration in sepsis patients considering
        the change in RRI values over 7 days from admission as a predictor of AKI development
  Acute kidney injury (AKI) is one of the most common problems in critically ill patients in
        the clinic. AKI can be caused by various factors, such as hypovolemia, shock, major surgery,
        trauma, and heart failure, of which sepsis is the most common
  observational model: Cohort
  time perspective: Prospective
  measure: Prediction of AKI development by renal resistance index (RRI)
  time frame: 7 days from admission
  description: AKI was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.
  The KDIGO guidelines define AKI as follows
  Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or
  Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or
  Urine volume <0.5 mL/kg/hour for six hours
  measure: Evaluation of fluid administration
  time frame: 7 days from admission
  description: RRI and other hypoperfusion markers after fluid challenge and divided into responder to fluid (Time 1 F) and non responder with noradrenaline administration (Time 1 N) .
  measure: Length of ICU stay
  time frame: 2 months from admission till discharge
  description: Length of ICU stay till discharge will be measured.
  measure: cumulative fluid balance over 7 days
  time frame: 7 days from admission
  description: Cumulative fluid balance over 7 days and urine output (intake -output) will be measured.
  measure: The incidence of 28 day mortality
  time frame: 28 days from admission
  description: The incidence of mortality will be measured at 28 day.
  arm group label: AKI group
  description: Acute kidney injury (AKI) was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.
  The KDIGO guidelines define AKI as follows:
  Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or
  Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or
  Urine volume <0.5 mL/kg/hour for six hours
  arm group label: Non AKI group
  description: Patients who will no develop Acute kidney injury (AKI).
  intervention type: Diagnostic Test
  intervention name: Renal resistive index
  description: The calculation formula for Renal resistive index (RRI) as follows :
  (systolic peak flow velocity _ diastolic minimum flow velocity )/systolic peak flow velocity .
  will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.
  The median value of each section will be used and the 3 median values of each kidney will be averaged.
  arm group label: AKI group
  arm group label: Non AKI group
  other name: Renal Doppler Ultrasound
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Safinaz A Aboelfetoh, MBBCh
  role: Principal Investigator
  affiliation: Anesthesiology, Faculty of Medicine, Tanta University, Egypt.
  last name: Safinaz A Aboelfetoh, MBBCh
  phone: 00201148855752
  email: noralamar34@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Safinaz Abdelkhalek Aboelfetoh
  investigator title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Acute Kidney Injury
  mesh term: Wounds and Injuries
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: The data will be available after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author.