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Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.

Primary Purpose

Acute on Chronic Liver Failure

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Albumin
Ascitic fluid
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute on Chronic Liver Failure

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥ 5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease (ACLF) admitted in the hospital.
  2. All Cirrhotics decompensated with ascites admitted in the hospital.
  3. Grade II/III ascites
  4. Need for paracentesis.

Exclusion Criteria:

  1. Age <12 or > 75 years
  2. Hepatocellular carcinoma
  3. Non cirrhotic ascites such as malignancy or tubercular peritonitis
  4. Serum Cr >1.5mg%
  5. Refractory septic shock
  6. Grade III/IV hepatic encephalopathy
  7. Abdominal wall cellulitis
  8. Active variceal bleed
  9. Respiratory, cardiac and renal failure
  10. Refusal to participate in the study

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Albumin

No Albumin

Arm Description

MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.

MVP (Modest Volume Paracentesis) of less than 5 litres without albumin.

Outcomes

Primary Outcome Measures

Total number of patients develop Circulatory Dysfunction because of paracentesis.

Secondary Outcome Measures

Survival
Total number of patients develop hepatorenal Syndrome.
Total number of patients develop hyponatremia.
Changes in aldosterone with volume of ascitic fluid tap
Changes in plasma renin activity

Full Information

First Posted
June 4, 2015
Last Updated
November 25, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02467348
Brief Title
Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.
Official Title
To Study the Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2015 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on chronic Liver Failure). ACLF will be randomize into Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8 gms/L of ascitic fluid Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albumin
Arm Type
Experimental
Arm Description
MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.
Arm Title
No Albumin
Arm Type
Active Comparator
Arm Description
MVP (Modest Volume Paracentesis) of less than 5 litres without albumin.
Intervention Type
Drug
Intervention Name(s)
Albumin
Intervention Description
Intravenous albumin 8 gms/L of ascitic fluid
Intervention Type
Drug
Intervention Name(s)
Ascitic fluid
Primary Outcome Measure Information:
Title
Total number of patients develop Circulatory Dysfunction because of paracentesis.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Survival
Time Frame
28 days
Title
Total number of patients develop hepatorenal Syndrome.
Time Frame
1 Year
Title
Total number of patients develop hyponatremia.
Time Frame
1 Year
Title
Changes in aldosterone with volume of ascitic fluid tap
Time Frame
1 Year
Title
Changes in plasma renin activity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥ 5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease (ACLF) admitted in the hospital. All Cirrhotics decompensated with ascites admitted in the hospital. Grade II/III ascites Need for paracentesis. Exclusion Criteria: Age <12 or > 75 years Hepatocellular carcinoma Non cirrhotic ascites such as malignancy or tubercular peritonitis Serum Cr >1.5mg% Refractory septic shock Grade III/IV hepatic encephalopathy Abdominal wall cellulitis Active variceal bleed Respiratory, cardiac and renal failure Refusal to participate in the study
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
31849085
Citation
Arora V, Vijayaraghavan R, Maiwall R, Sahney A, Thomas SS, Ali R, Jain P, Kumar G, Sarin SK. Paracentesis-Induced Circulatory Dysfunction With Modest-Volume Paracentesis Is Partly Ameliorated by Albumin Infusion in Acute-on-Chronic Liver Failure. Hepatology. 2020 Sep;72(3):1043-1055. doi: 10.1002/hep.31071. Epub 2020 Jul 9.
Results Reference
derived

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Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.

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