<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/NCT04463745</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS - Liver Transplant-3</org_study_id>
    <nct_id>NCT04463745</nct_id>
  </id_info>
  <brief_title>Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation</brief_title>
  <acronym>OIL</acronym>
  <official_title>Organ Dysfunction Associated With Intraabdominal Pressures in Liver Transplantation</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>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>
      Patients with end stage liver disease have varying degrees of intra-abdominal hypertension&#xD;
      (IAH) due to the presence of ascites. The perioperative events may either relieve or&#xD;
      aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on&#xD;
      various organ systems. There is an increase in intracranial pressures and a decrease in&#xD;
      cerebral perfusion pressures associated with IAH . In the heart, there is an increase of&#xD;
      right atrial pressures, increase in systemic vascular resistance and decrease in cardiac&#xD;
      output . Pulmonary complications include increase in the peak, mean and plateau airway&#xD;
      pressures, with decreased compliance . Renal dysfunction is an early effect of raised&#xD;
      intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the&#xD;
      medulla, mechanical compression of the kidneys and increased pressures in the renal veins .&#xD;
      We would study the intra-abdominal pressures in liver transplant recipients and record&#xD;
      hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days&#xD;
      for neurological, respiratory, cardiac and renal complications will be collected, along with&#xD;
      hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and&#xD;
      these outcomes will be analysed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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>28 day mortality</measure>
    <time_frame>28 days</time_frame>
    <description>mortality of any cause in the fist 28 days after transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>duration of icu stay</measure>
    <time_frame>28 days</time_frame>
    <description>time period spent in the intensive care unit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury in 1st week</measure>
    <time_frame>7 days</time_frame>
    <description>incidence of acute kidney injury in 1 week of transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>7 days</time_frame>
    <description>includes duration of ventilation, incidence of vap</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major neurological complications</measure>
    <time_frame>7 days</time_frame>
    <description>any major neurological event</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Intra-Abdominal Hypertension</condition>
  <condition>Cirrhosis, Liver</condition>
  <condition>Organ Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>Liver Transplant Recipients</arm_group_label>
    <description>adult patients undergoing liver transplantation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing liver transplantation for various indications , including chronic liver&#xD;
        disease due to alcohol, NASH , viral hepatitis among others.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing liver transplantation&#xD;
&#xD;
          -  18 to 65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant patients&#xD;
&#xD;
          -  primary diagnosis of Acute liver failure and 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 Ponnappan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Liver and Biliary Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karthik Ponnappan</last_name>
    <phone>+919840163951</phone>
    <email>kdtkp@yahoo.com</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Karthik Ponnappan T, DM</last_name>
      <phone>9840163951</phone>
      <email>karthik.kaper@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2020</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 9, 2020</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>organ dysfunction</keyword>
  <keyword>intra-abdominal pressure</keyword>
  <keyword>liver transplantation</keyword>
  <keyword>liver cirrhosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intra-Abdominal Hypertension</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fibrosis</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/NCT04463745
org study id: ILBS - Liver Transplant-3
nct id: NCT04463745
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with end stage liver disease have varying degrees of intra-abdominal hypertension
      (IAH) due to the presence of ascites. The perioperative events may either relieve or
      aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on
      various organ systems. There is an increase in intracranial pressures and a decrease in
      cerebral perfusion pressures associated with IAH . In the heart, there is an increase of
      right atrial pressures, increase in systemic vascular resistance and decrease in cardiac
      output . Pulmonary complications include increase in the peak, mean and plateau airway
      pressures, with decreased compliance . Renal dysfunction is an early effect of raised
      intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the
      medulla, mechanical compression of the kidneys and increased pressures in the renal veins .
      We would study the intra-abdominal pressures in liver transplant recipients and record
      hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days
      for neurological, respiratory, cardiac and renal complications will be collected, along with
      hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and
      these outcomes will be analysed.
observational model: Cohort
time perspective: Prospective
measure: 28 day mortality
time frame: 28 days
description: mortality of any cause in the fist 28 days after transplantation
measure: duration of icu stay
time frame: 28 days
description: time period spent in the intensive care unit
measure: Acute kidney injury in 1st week
time frame: 7 days
description: incidence of acute kidney injury in 1 week of transplantation
measure: Respiratory complications
time frame: 7 days
description: includes duration of ventilation, incidence of vap
measure: major neurological complications
time frame: 7 days
description: any major neurological event
arm group label: Liver Transplant Recipients
description: adult patients undergoing liver transplantation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Karthik Ponnappan
role: Principal Investigator
affiliation: Institute of Liver and Biliary Sciences
last name: Karthik Ponnappan
phone: +919840163951
email: kdtkp@yahoo.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: Intra-Abdominal Hypertension
mesh term: Liver Cirrhosis
mesh term: Liver Diseases
mesh term: Fibrosis