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

November 25, 2017 updated by: Institute of Liver and Biliary Sciences, India

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Albumin
MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.
Drug: Albumin
Intravenous albumin 8 gms/L of ascitic fluid
Drug: Ascitic fluid
Active Comparator: No Albumin
MVP (Modest Volume Paracentesis) of less than 5 litres without albumin.
Drug: Ascitic fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of patients develop Circulatory Dysfunction because of paracentesis.
Time Frame: 1 Year
1 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 28 days
28 days
Total number of patients develop hyponatremia.
Time Frame: 1 Year
1 Year
Total number of patients develop hepatorenal Syndrome.
Time Frame: 1 Year
1 Year
Changes in aldosterone with volume of ascitic fluid tap
Time Frame: 1 Year
1 Year
Changes in plasma renin activity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2015

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-ACLF and Cirrhosis-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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