<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/NCT04462874</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS - Liver Transplant-4</org_study_id>
    <nct_id>NCT04462874</nct_id>
  </id_info>
  <brief_title>Mean Systemic Filling Pressure Trends in Liver Transplant Recipients</brief_title>
  <official_title>Mean Systemic Filling Pressure Trends in Liver Transplant Recipients - a Prospective Observational Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</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>
      Patients with end stage liver disease undergoing liver transplantation have varying degrees&#xD;
      of intraoperative haemodynamic unstability during various phases of transplantation. It is&#xD;
      difficult to determine the cause for hemodynamic instability in these patients and to predict&#xD;
      the best treatments. Currently, cardiovascular resuscitation options are triggered by&#xD;
      arterial pressure and cardiac output (CO) measures, focusing on the oxygen delivery side of&#xD;
      the circulation. The primary determinants of cardiac output reside on the venous side. Veins&#xD;
      are 30-50 times more compliant than arteries and contain approximately 75% of the total blood&#xD;
      volume. Mean systemic filling pressure provides vital information on this venous side of the&#xD;
      circulation. Mean systemic filling pressure , which is defined as the pressure equal to the&#xD;
      pressure which would be measured if the heart should suddenly stop pumping and all (arterial&#xD;
      and venous) the pressures in the entire circulatory system should be brought to equilibrium&#xD;
      instantaneously, is a good, complete and reliable reflection of the total intravascular fluid&#xD;
      compartment. We would study the Mean systemic filling pressure in liver transplant recipients&#xD;
      and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data&#xD;
      for 7 days for respiratory, cardiac and renal complications will be collected, along with&#xD;
      hospital stay, ICU stay and mortality. The association between Mean systemic filling pressure&#xD;
      and these outcomes will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 15, 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>mean systemic filling pressures(MSFP)</measure>
    <time_frame>1 day</time_frame>
    <description>MSFP trends during liver transplantation, hourly</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>icu stay</measure>
    <time_frame>28 days</time_frame>
    <description>duration of stay in the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28 day mortality</measure>
    <time_frame>28 days</time_frame>
    <description>mortality by all causes till day 28</description>
  </secondary_outcome>
  <other_outcome>
    <measure>respiratory complications</measure>
    <time_frame>7 days</time_frame>
    <description>number of participants needing reintubation, prolonged mechanical ventilation, intercostal drain placement</description>
  </other_outcome>
  <other_outcome>
    <measure>acute kidney injury(AKI)</measure>
    <time_frame>7 days</time_frame>
    <description>AKI incidence upto 7 days</description>
  </other_outcome>
  <other_outcome>
    <measure>cardiac complication</measure>
    <time_frame>7 days</time_frame>
    <description>number of participants with significant arrhythmias and ischemia associated with hypotension</description>
  </other_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Liver Transplant; Complications</condition>
  <condition>Liver Diseases</condition>
  <condition>Hemodynamic Instability</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with liver diseases undergoing liver transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing liver transplantation 18-65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant patients acute liver failure, acute on chronic liver failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karthik T Ponnappan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Liver and Biliary Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Liver and Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liver transplantation</keyword>
  <keyword>mean systemic filling pressure</keyword>
  <keyword>advanced hemodynamic monitoring</keyword>
  <keyword>liver cirrhosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04462874
org study id: ILBS - Liver Transplant-4
nct id: NCT04462874
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with end stage liver disease undergoing liver transplantation have varying degrees
      of intraoperative haemodynamic unstability during various phases of transplantation. It is
      difficult to determine the cause for hemodynamic instability in these patients and to predict
      the best treatments. Currently, cardiovascular resuscitation options are triggered by
      arterial pressure and cardiac output (CO) measures, focusing on the oxygen delivery side of
      the circulation. The primary determinants of cardiac output reside on the venous side. Veins
      are 30-50 times more compliant than arteries and contain approximately 75% of the total blood
      volume. Mean systemic filling pressure provides vital information on this venous side of the
      circulation. Mean systemic filling pressure , which is defined as the pressure equal to the
      pressure which would be measured if the heart should suddenly stop pumping and all (arterial
      and venous) the pressures in the entire circulatory system should be brought to equilibrium
      instantaneously, is a good, complete and reliable reflection of the total intravascular fluid
      compartment. We would study the Mean systemic filling pressure in liver transplant recipients
      and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data
      for 7 days for respiratory, cardiac and renal complications will be collected, along with
      hospital stay, ICU stay and mortality. The association between Mean systemic filling pressure
      and these outcomes will be analyzed.
observational model: Cohort
time perspective: Prospective
measure: mean systemic filling pressures(MSFP)
time frame: 1 day
description: MSFP trends during liver transplantation, hourly
measure: icu stay
time frame: 28 days
description: duration of stay in the intensive care unit
measure: 28 day mortality
time frame: 28 days
description: mortality by all causes till day 28
measure: respiratory complications
time frame: 7 days
description: number of participants needing reintubation, prolonged mechanical ventilation, intercostal drain placement
measure: acute kidney injury(AKI)
time frame: 7 days
description: AKI incidence upto 7 days
measure: cardiac complication
time frame: 7 days
description: number of participants with significant arrhythmias and ischemia associated with hypotension
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Karthik T Ponnappan
role: Principal Investigator
affiliation: Institute of Liver and Biliary Sciences
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Diseases