<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/NCT03005587</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-06</org_study_id>
    <nct_id>NCT03005587</nct_id>
  </id_info>
  <brief_title>Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation</brief_title>
  <official_title>Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a prospective observational study in Chronic Liver Disease patients admitted or seen in&#xD;
      OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will&#xD;
      be conducted in a period of three months starting September 2016 in sample size of 80 . A&#xD;
      detailed proforma including history and examination and routine blood investigations will be&#xD;
      noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar&#xD;
      activities will be repeated at every visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of Funds&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 31, 2016</start_date>
  <completion_date type="Anticipated">March 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2017</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>Spontaneous recovery or liver transplant or death in both groups</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cause of acute decompensation</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity and duration of prior as well as present decompensation</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Causes of death in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Profile of patient undergone transplant in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sepsis in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Inflammatory Response Syndrome in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in severity assessment Indices Child Pugh Turcotte in both groups.</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in severity assessment Indices CLIF score in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Decompensation in Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Cirrhotics with no previous decompensation</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cirrhotics with previous one or more than one decompensation</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic liver disease patients admitted or seen in Out Patient Department, Department of&#xD;
        Hepatology, Institute of Liver &amp; Biliary Sciences, India.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice,&#xD;
             Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation.&#xD;
&#xD;
          2. Age 18-70 years&#xD;
&#xD;
          3. Valid consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. HepatoCellular Carcinoma&#xD;
&#xD;
          2. Admitted and survival less than 48 hrs&#xD;
&#xD;
          3. Pregnant&#xD;
&#xD;
          4. Acute Liver Failure&#xD;
&#xD;
          5. Post transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>June 2018</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>June 22, 2018</last_update_submitted>
  <last_update_submitted_qc>June 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT03005587
org study id: ILBS-Cirrhosis-06
nct id: NCT03005587
lead sponsor: 
has dmc: No
This a prospective observational study in Chronic Liver Disease patients admitted or seen in
      OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will
      be conducted in a period of three months starting September 2016 in sample size of 80 . A
      detailed proforma including history and examination and routine blood investigations will be
      noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar
      activities will be repeated at every visit.
observational model: Cohort
time perspective: Prospective
measure: Spontaneous recovery or liver transplant or death in both groups
time frame: 90 days
measure: Cause of acute decompensation
time frame: 3 months
measure: Severity and duration of prior as well as present decompensation
time frame: 3 months
measure: Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.
time frame: 3 months
measure: Causes of death in both groups
time frame: 3 months
measure: Profile of patient undergone transplant in both groups
time frame: 3 months
measure: Sepsis in both groups
time frame: 3 months
measure: Systemic Inflammatory Response Syndrome in both groups
time frame: 3 months
measure: Improvement in severity assessment Indices Child Pugh Turcotte in both groups.
time frame: 3 months
measure: Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups
time frame: 3 months
measure: Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups
time frame: 3 months
measure: Improvement in severity assessment Indices CLIF score in both groups
time frame: 3 months
arm group label: Cirrhotics with no previous decompensation
arm group label: Cirrhotics with previous one or more than one decompensation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
sharing ipd: No