<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/NCT04406298</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-29</org_study_id>
    <nct_id>NCT04406298</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites</brief_title>
  <official_title>Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites- A Randomized Controlled Trial (I-CARE)</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>
      The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per&#xD;
      day) paracentesis through an indwelling catheter for up to 5 days in comparison with large&#xD;
      volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3&#xD;
      months. The project will be conducted at ILBS between April 2020 and March 2021. The concept&#xD;
      of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling&#xD;
      rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the&#xD;
      incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion&#xD;
      and exclusion criteria, after taking informed consent from the patient or their relatives.&#xD;
&#xD;
      The expected outcomes are&#xD;
&#xD;
      Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least&#xD;
      50 % reduction on need for large volume paracentesis after a short duration (5day)&#xD;
      intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in&#xD;
      comparison to a single large volume paracentesis in the next 3 months.&#xD;
&#xD;
      Secondary outcome:&#xD;
&#xD;
      1. Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D,&#xD;
      60 D and 90 D follow up, to assess between the groups&#xD;
&#xD;
        -  Need for repeated paracentesis : Number assessed&#xD;
&#xD;
        -  AKI : Improvement or worsening of renal functions&#xD;
&#xD;
        -  Hepatic encephalopathy: Grading as per West Haven Classification&#xD;
&#xD;
        -  Hyponatremia&#xD;
&#xD;
        -  Diuretic tolerability : Dose and duration tolerated&#xD;
&#xD;
        -  Bacterial peritonitis : Ascitic fluid neutrophil count &gt; 250 cells/cumm&#xD;
&#xD;
        -  Transplant free survival&#xD;
&#xD;
        -  Risk of procedure related complications&#xD;
&#xD;
        -  Changes in MELD or CTP between the groups ( Improvement vs worsening )&#xD;
&#xD;
        -  Need for hospitalization between the groups&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 4, 2020</start_date>
  <completion_date type="Anticipated">May 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups</measure>
    <time_frame>3 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants which requires repeated paracentesis in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants which requires repeated paracentesis in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants which requires for repeated paracentesis in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with AKI : Improvement or worsening of renal functions in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with AKI : Improvement or worsening of renal functions in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with AKI : Improvement or worsening of renal functions in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Hepatic Encephalopathy in both groups</measure>
    <time_frame>30 days</time_frame>
    <description>Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Hepatic Encephalopathy in both groups</measure>
    <time_frame>60 days</time_frame>
    <description>Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Hepatic Encephalopathy in both groups</measure>
    <time_frame>90 days</time_frame>
    <description>Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Hyponatremia in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Hyponatremia in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Hyponatremia in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diuretic tolerability : Dose tolerated in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diuretic tolerability : Dose tolerated in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diuretic tolerability : Dose tolerated in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diuretic tolerability : Duration tolerated in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diuretic tolerability : Duration tolerated in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diuretic tolerability : Duration tolerated in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacterial peritonitis : Ascitic fluid neutrophil count &gt; 250 cells/cumm in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacterial peritonitis : Ascitic fluid neutrophil count &gt; 250 cells/cumm in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacterial peritonitis : Ascitic fluid neutrophil count &gt; 250 cells/cumm in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant free survival in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant free survival in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant free survival in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants develop adverse events associated with procedure in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants develop adverse events associated with procedure in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants develop adverse events associated with procedure in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Model for End Stage Liver Disease Score in both groups</measure>
    <time_frame>30 days</time_frame>
    <description>MELD Score ranges from 6 to 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Model for End Stage Liver Disease Score in both groups</measure>
    <time_frame>60 days</time_frame>
    <description>MELD Score ranges from 6 to 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Model for End Stage Liver Disease Score in both groups</measure>
    <time_frame>90 days</time_frame>
    <description>MELD Score ranges from 6 to 40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CTP (Child-Turcotte-Pugh) Score in both groups</measure>
    <time_frame>30 days</time_frame>
    <description>Child class A: &lt; 7 points. Child class B: 7-9 points. Child class C: ≥10 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CTP (Child-Turcotte-Pugh) Score in both groups</measure>
    <time_frame>60 days</time_frame>
    <description>Child class A: &lt; 7 points. Child class B: 7-9 points. Child class C: ≥10 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CTP (Child-Turcotte-Pugh) Score in both groups</measure>
    <time_frame>90 days</time_frame>
    <description>Child class A: &lt; 7 points. Child class B: 7-9 points. Child class C: ≥10 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients required hospitalization between the groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients required hospitalization between the groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients required hospitalization between the groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Small Quantity Paracentesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Large Volume Paracentesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Large Volume Paracentesis &gt; 5 litres</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>small quantity paracentesis</intervention_name>
    <description>Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days</description>
    <arm_group_label>Small Quantity Paracentesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Large Volume Paracentesis</intervention_name>
    <description>Large Volume Paracentesis &gt; 5litres</description>
    <arm_group_label>Large Volume Paracentesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function&#xD;
             (S.creatinine &lt; 2 mg/dl).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CTP &gt;12, MELD&gt;25&#xD;
&#xD;
          -  Prior or current Spontaneous Bacterial Peritonitis (SBP)&#xD;
&#xD;
          -  Recurrent or current overt hepatic encephalopathy&#xD;
&#xD;
          -  Serum Creatinine &gt;2&#xD;
&#xD;
          -  HVOTO (Hepatic Venous Outflow Tract Obstruction)&#xD;
&#xD;
          -  Hepatic or extrahepatic malignancy&#xD;
&#xD;
          -  Recent UGI bleed&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Serum Sodium &lt; 120&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dr Manasa Alla, MD</last_name>
    <phone>01146300000</phone>
    <email>manasa1512@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Liver &amp; 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>Dr Manasa Alla, MD</last_name>
      <phone>01146300000</phone>
      <email>manasa1512@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</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>Ascites</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04406298
org study id: ILBS-Cirrhosis-29
nct id: NCT04406298
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per
      day) paracentesis through an indwelling catheter for up to 5 days in comparison with large
      volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3
      months. The project will be conducted at ILBS between April 2020 and March 2021. The concept
      of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling
      rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the
      incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion
      and exclusion criteria, after taking informed consent from the patient or their relatives.

      The expected outcomes are

      Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least
      50 % reduction on need for large volume paracentesis after a short duration (5day)
      intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in
      comparison to a single large volume paracentesis in the next 3 months.

      Secondary outcome:

      1. Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D,
      60 D and 90 D follow up, to assess between the groups

        -  Need for repeated paracentesis : Number assessed

        -  AKI : Improvement or worsening of renal functions

        -  Hepatic encephalopathy: Grading as per West Haven Classification

        -  Hyponatremia

        -  Diuretic tolerability : Dose and duration tolerated

        -  Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm

        -  Transplant free survival

        -  Risk of procedure related complications

        -  Changes in MELD or CTP between the groups ( Improvement vs worsening )

        -  Need for hospitalization between the groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups
time frame: 3 Months
measure: Number of participants which requires repeated paracentesis in both groups
time frame: 30 days
measure: Number of participants which requires repeated paracentesis in both groups
time frame: 60 days
measure: Number of participants which requires for repeated paracentesis in both groups
time frame: 90 days
measure: Number of participants with AKI : Improvement or worsening of renal functions in both groups
time frame: 30 days
measure: Number of participants with AKI : Improvement or worsening of renal functions in both groups
time frame: 60 days
measure: Number of participants with AKI : Improvement or worsening of renal functions in both groups
time frame: 90 days
measure: Number of participants with Hepatic Encephalopathy in both groups
time frame: 30 days
description: Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups
measure: Number of participants with Hepatic Encephalopathy in both groups
time frame: 60 days
description: Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups
measure: Number of participants with Hepatic Encephalopathy in both groups
time frame: 90 days
description: Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups
measure: Number of participants with Hyponatremia in both groups
time frame: 30 days
measure: Number of participants with Hyponatremia in both groups
time frame: 60 days
measure: Number of participants with Hyponatremia in both groups
time frame: 90 days
measure: Diuretic tolerability : Dose tolerated in both groups
time frame: 30 days
measure: Diuretic tolerability : Dose tolerated in both groups
time frame: 60 days
measure: Diuretic tolerability : Dose tolerated in both groups
time frame: 90 days
measure: Diuretic tolerability : Duration tolerated in both groups
time frame: 30 days
measure: Diuretic tolerability : Duration tolerated in both groups
time frame: 60 days
measure: Diuretic tolerability : Duration tolerated in both groups
time frame: 90 days
measure: Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
time frame: 30 days
measure: Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
time frame: 60 days
measure: Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
time frame: 90 days
measure: Transplant free survival in both groups
time frame: 30 days
measure: Transplant free survival in both groups
time frame: 60 days
measure: Transplant free survival in both groups
time frame: 90 days
measure: Number of participants develop adverse events associated with procedure in both groups
time frame: 30 days
measure: Number of participants develop adverse events associated with procedure in both groups
time frame: 60 days
measure: Number of participants develop adverse events associated with procedure in both groups
time frame: 90 days
measure: Change in Model for End Stage Liver Disease Score in both groups
time frame: 30 days
description: MELD Score ranges from 6 to 40
measure: Change in Model for End Stage Liver Disease Score in both groups
time frame: 60 days
description: MELD Score ranges from 6 to 40
measure: Change in Model for End Stage Liver Disease Score in both groups
time frame: 90 days
description: MELD Score ranges from 6 to 40
measure: Change in CTP (Child-Turcotte-Pugh) Score in both groups
time frame: 30 days
description: Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points
measure: Change in CTP (Child-Turcotte-Pugh) Score in both groups
time frame: 60 days
description: Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points
measure: Change in CTP (Child-Turcotte-Pugh) Score in both groups
time frame: 90 days
description: Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points
measure: Number of patients required hospitalization between the groups
time frame: 30 days
measure: Number of patients required hospitalization between the groups
time frame: 60 days
measure: Number of patients required hospitalization between the groups
time frame: 90 days
arm group label: Small Quantity Paracentesis
arm group type: Experimental
description: Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days.
arm group label: Large Volume Paracentesis
arm group type: Active Comparator
description: Large Volume Paracentesis > 5 litres
intervention type: Procedure
intervention name: small quantity paracentesis
description: Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
arm group label: Small Quantity Paracentesis
intervention type: Procedure
intervention name: Large Volume Paracentesis
description: Large Volume Paracentesis > 5litres
arm group label: Large Volume Paracentesis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dr Manasa Alla, MD
phone: 01146300000
email: manasa1512@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Ascites
sharing ipd: Undecided