<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/NCT04426032</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU M S 299 / 2020</org_study_id>
    <nct_id>NCT04426032</nct_id>
  </id_info>
  <brief_title>Predictive Value of Doppler RSI for Prediction of AKI in Septic Patients in ICU</brief_title>
  <official_title>Predictive Value of Doppler Renal Resistive Index for Prediction of Acute Kidney Injury in Septic Patients in Intensive Care Unit.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal&#xD;
      vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal&#xD;
      Resistive Index (RRI)) could become part of vital organ function assessment using Doppler&#xD;
      ultrasound.&#xD;
&#xD;
      The aim of this study is to predict AKI in septic patients in ICU by measuring RRI on&#xD;
      admission by comparing two groups of patients, first group with RRI of normal value (0.6-0.7)&#xD;
      and the other group with high RRI more than 0.7 and both with normal renal function on&#xD;
      admission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who have criteria of sepsis, with normal renal function on admission will undergo&#xD;
      Renal Doppler Ultrasound examination to measure Renal resistive index.&#xD;
&#xD;
      Patients will be divided into 2 groups:&#xD;
&#xD;
        1. Group (A) patients with renal resistive index between 0.6 and 0.7 (normal RRI).&#xD;
&#xD;
        2. Group (B) patients with renal resistive index more than 0.7 (high RRI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>incidence of AKI</measure>
    <time_frame>1 day at admission</time_frame>
    <description>incidence of AKI related to Renal resistive index.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>APACHE III score</measure>
    <time_frame>1 day at admission</time_frame>
    <description>Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 299 worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APACHE IV score</measure>
    <time_frame>1 day at admission</time_frame>
    <description>Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 286 worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>1 day at admission</time_frame>
    <description>Sequential Organ Failure Assessment (SOFA) score. Score Range (0 better - 24 worse)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Patients with RRI between 0.6 and 0.7</arm_group_label>
    <description>Normal renal resistive index</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with RRI more than 0.7</arm_group_label>
    <description>High renal resistive index</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Renal Doppler Ultrasound</intervention_name>
    <description>Measurement of Renal resistive index</description>
    <arm_group_label>Patients with RRI between 0.6 and 0.7</arm_group_label>
    <arm_group_label>Patients with RRI more than 0.7</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of both sex admitted to ICU, with criteria of sepsis, and normal renal function on&#xD;
        admission.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who have criteria of sepsis on admission which include two or more of SIRS&#xD;
             which include: (Temperature &gt;38°C or &lt;36°C, Heart rate &gt;90/min, Respiratory rate&#xD;
             &gt;20/min or PaCO2 &lt;32mmHg (4.3kPa) and White blood cell count &gt;12000/mm3 or &lt;4000/mm3&#xD;
             or &gt;10% immature bands.) in addition to suspected or confirmed infection.&#xD;
&#xD;
          2. Patients who have normal renal function on admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently recovering from an AKI at the time of inclusion and Renal impairment on&#xD;
             admission.&#xD;
&#xD;
          2. Patients with obstructive renal failure, renal artery stenosis were excluded from this&#xD;
             study.&#xD;
&#xD;
          3. Patients on chemotherapy and/or radiotherapy.&#xD;
&#xD;
          4. Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Saleh Ahmed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer of Anesthesia and Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed Saeed Abdelaziz, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Anesthesia and Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mona Refaat Hosney, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor of Anesthesia and Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Abdelsattar Abuelmajd, MBBCH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Candidate of master degree in general intensive care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University Hospitals</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed Saleh Ahmed Massoud</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia and Intensive Care</investigator_title>
  </responsible_party>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>Sepsis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is not yet known if there will be a plan to make IPD available.</ipd_description>
  </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/NCT04426032
org study id: FMASU M S 299 / 2020
nct id: NCT04426032
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal
      vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal
      Resistive Index (RRI)) could become part of vital organ function assessment using Doppler
      ultrasound.

      The aim of this study is to predict AKI in septic patients in ICU by measuring RRI on
      admission by comparing two groups of patients, first group with RRI of normal value (0.6-0.7)
      and the other group with high RRI more than 0.7 and both with normal renal function on
      admission.
Patients who have criteria of sepsis, with normal renal function on admission will undergo
      Renal Doppler Ultrasound examination to measure Renal resistive index.

      Patients will be divided into 2 groups:

        1. Group (A) patients with renal resistive index between 0.6 and 0.7 (normal RRI).

        2. Group (B) patients with renal resistive index more than 0.7 (high RRI).
observational model: Cohort
time perspective: Prospective
measure: incidence of AKI
time frame: 1 day at admission
description: incidence of AKI related to Renal resistive index.
measure: APACHE III score
time frame: 1 day at admission
description: Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 299 worse)
measure: APACHE IV score
time frame: 1 day at admission
description: Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 286 worse)
measure: SOFA score
time frame: 1 day at admission
description: Sequential Organ Failure Assessment (SOFA) score. Score Range (0 better - 24 worse)
arm group label: Patients with RRI between 0.6 and 0.7
description: Normal renal resistive index
arm group label: Patients with RRI more than 0.7
description: High renal resistive index
intervention type: Diagnostic Test
intervention name: Renal Doppler Ultrasound
description: Measurement of Renal resistive index
arm group label: Patients with RRI between 0.6 and 0.7
arm group label: Patients with RRI more than 0.7
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
last name: Mohamed Saleh Ahmed, MD
role: Study Director
affiliation: Lecturer of Anesthesia and Intensive Care
last name: Mohammed Saeed Abdelaziz, MD
role: Study Chair
affiliation: Professor of Anesthesia and Intensive Care
last name: Mona Refaat Hosney, MD
role: Study Director
affiliation: Assistant Professor of Anesthesia and Intensive Care
last name: Ahmed Abdelsattar Abuelmajd, MBBCH
role: Principal Investigator
affiliation: Candidate of master degree in general intensive care
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed Saleh Ahmed Massoud
investigator title: Lecturer of Anesthesia and Intensive Care
mesh term: Acute Kidney Injury
sharing ipd: Undecided
ipd description: It is not yet known if there will be a plan to make IPD available.