<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/NCT03805321</url>
  </required_header>
  <id_info>
    <org_study_id>N-138-2018</org_study_id>
    <nct_id>NCT03805321</nct_id>
  </id_info>
  <brief_title>The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness</brief_title>
  <official_title>The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness Using Mini-fluid Challenge Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fluid therapy is an essential component of the management of patients with acute circulatory&#xD;
      failure. Nevertheless, unnecessary administration of fluids in non-responders is harmful.&#xD;
      Thus, the concept of fluid responsiveness has been suggested to guide fluid administration in&#xD;
      critically ill patients to avoid either over or under-transfusion. The aim of this work is to&#xD;
      investigate the ability of peripheral perfusion index to predict the hemodynamic response to&#xD;
      mini-fluid challenge in patients with septic shock .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The concept of fluid responsiveness has been suggested to guide fluid administration in&#xD;
      critically ill patients to avoid either over or under-transfusion.&#xD;
&#xD;
      Several methods have been suggested to detect fluid responsiveness. Mini fluid challenge with&#xD;
      concomitant monitoring of stroke volume is one of the most robust methods for pre-load&#xD;
      challenge.&#xD;
&#xD;
      The main foreshortening of mini fluid challenge method is the need for a real-time cardiac&#xD;
      output monitor, to track the instantaneous change of stroke vole with changing body position.&#xD;
      Finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make&#xD;
      the test more applicable without the need for advanced hemodynamic monitors.&#xD;
&#xD;
      There is a growing interest in the use of perfusion indices in assessment of fluid&#xD;
      responsiveness. Perfusion indices are measures for adequacy of oxygen delivery in peripheral&#xD;
      tissues; thus, they were hypothesized to be possible surrogates of cardiac output. Peripheral&#xD;
      perfusion index represents &quot;the ratio between the pulsatile and non-pulsatile component of&#xD;
      the light reaching the pulse oximeter&quot; . Peripheral perfusion index has been considered as a&#xD;
      numerical non-invasive measure for peripheral perfusion. PPI has the advantage over other&#xD;
      perfusion indices that it a non-invasive, user-friendly monitor.&#xD;
&#xD;
      The aim of this work is to investigate the ability of peripheral perfusion index to predict&#xD;
      the hemodynamic response to mini-fluid challenge in patients with septic shock.&#xD;
&#xD;
      Mini-fluid challenge test will be performed by infusion of 200 mL Lactated Ringer's solution&#xD;
      over 1 minute. Velocity time integral will be monitored using Transthoracic echocardiography&#xD;
      at the left ventricular outflow tract at the apical five-chamber view. Cardiac output will be&#xD;
      calculated, and the patient will be considered fluid-responder if cardiac output increased by&#xD;
      10% after fluid challenge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2019</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 25, 2019</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>Peripheral perfusion index</measure>
    <time_frame>2 hours</time_frame>
    <description>It is a number describing the ratio between pulsatile and non-pulsatile blood flow measured by pulse oximeter. It is measured in percent. with the best value of 20% and the worst value of 0.1%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Velocity time integral</measure>
    <time_frame>2 hours</time_frame>
    <description>it is a parameter measured from Doppler across the left ventricular outflow tract. It is calculated by dividing the blood velocity by time and measured in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure</measure>
    <time_frame>2 hours</time_frame>
    <description>Mean arterial blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central venous pressure</measure>
    <time_frame>2 hours</time_frame>
    <description>Central venous pressure measured from a central venous catheter. It is measured in cmH2o</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic arterial blood pressure</measure>
    <time_frame>2 hours</time_frame>
    <description>Systolic arterial blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic arterial blood pressure</measure>
    <time_frame>2 hours</time_frame>
    <description>Diastolic arterial blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>2 hours</time_frame>
    <description>The amount of blood pumped by the heart in one minute. it is measured as liters per minute</description>
  </secondary_outcome>
  <enrollment type="Actual">57</enrollment>
  <condition>Septic Shock</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include septic shock patients undergoing fluid resuscitation. Patients will&#xD;
        be enrolled during evaluation of fluid responsiveness.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Septic shock patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evident blood loss&#xD;
&#xD;
          -  Peripheral vascular disorders&#xD;
&#xD;
          -  Upper limb injury or burns&#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>Ahmed Shash, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Head of department of anesthesia, Cairo University, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Mohamed Hasanin</name>
      <address>
        <city>Cairo</city>
        <zip>11432</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Hasanin</investigator_full_name>
    <investigator_title>Assistant professor of anesthesia and critical care</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
  </condition_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/NCT03805321
org study id: N-138-2018
nct id: NCT03805321
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fluid therapy is an essential component of the management of patients with acute circulatory
      failure. Nevertheless, unnecessary administration of fluids in non-responders is harmful.
      Thus, the concept of fluid responsiveness has been suggested to guide fluid administration in
      critically ill patients to avoid either over or under-transfusion. The aim of this work is to
      investigate the ability of peripheral perfusion index to predict the hemodynamic response to
      mini-fluid challenge in patients with septic shock .
The concept of fluid responsiveness has been suggested to guide fluid administration in
      critically ill patients to avoid either over or under-transfusion.

      Several methods have been suggested to detect fluid responsiveness. Mini fluid challenge with
      concomitant monitoring of stroke volume is one of the most robust methods for pre-load
      challenge.

      The main foreshortening of mini fluid challenge method is the need for a real-time cardiac
      output monitor, to track the instantaneous change of stroke vole with changing body position.
      Finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make
      the test more applicable without the need for advanced hemodynamic monitors.

      There is a growing interest in the use of perfusion indices in assessment of fluid
      responsiveness. Perfusion indices are measures for adequacy of oxygen delivery in peripheral
      tissues; thus, they were hypothesized to be possible surrogates of cardiac output. Peripheral
      perfusion index represents "the ratio between the pulsatile and non-pulsatile component of
      the light reaching the pulse oximeter" . Peripheral perfusion index has been considered as a
      numerical non-invasive measure for peripheral perfusion. PPI has the advantage over other
      perfusion indices that it a non-invasive, user-friendly monitor.

      The aim of this work is to investigate the ability of peripheral perfusion index to predict
      the hemodynamic response to mini-fluid challenge in patients with septic shock.

      Mini-fluid challenge test will be performed by infusion of 200 mL Lactated Ringer's solution
      over 1 minute. Velocity time integral will be monitored using Transthoracic echocardiography
      at the left ventricular outflow tract at the apical five-chamber view. Cardiac output will be
      calculated, and the patient will be considered fluid-responder if cardiac output increased by
      10% after fluid challenge.
observational model: Cohort
time perspective: Prospective
measure: Peripheral perfusion index
time frame: 2 hours
description: It is a number describing the ratio between pulsatile and non-pulsatile blood flow measured by pulse oximeter. It is measured in percent. with the best value of 20% and the worst value of 0.1%
measure: Velocity time integral
time frame: 2 hours
description: it is a parameter measured from Doppler across the left ventricular outflow tract. It is calculated by dividing the blood velocity by time and measured in cm
measure: Mean arterial blood pressure
time frame: 2 hours
description: Mean arterial blood pressure measured in mmHg
measure: Central venous pressure
time frame: 2 hours
description: Central venous pressure measured from a central venous catheter. It is measured in cmH2o
measure: Systolic arterial blood pressure
time frame: 2 hours
description: Systolic arterial blood pressure measured in mmHg
measure: Diastolic arterial blood pressure
time frame: 2 hours
description: Diastolic arterial blood pressure measured in mmHg
measure: Cardiac output
time frame: 2 hours
description: The amount of blood pumped by the heart in one minute. it is measured as liters per minute
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Shash, Professor
role: Study Director
affiliation: Head of department of anesthesia, Cairo University, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hasanin
investigator title: Assistant professor of anesthesia and critical care
mesh term: Shock, Septic
sharing ipd: No