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OpenTrials
Completed

NCT Number: NCT02467348

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

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

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Key information

Conditions

Acute on Chronic Liver Failure Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALBUMIN

Drug

Intravenous albumin 8 gms/L of ascitic fluid

ascitic fluid

Drug

Primary outcomes

  1. Total number of patients develop Circulatory Dysfunction because of paracentesis.

    Time frame: 1 Year

Secondary outcomes

  1. Survival

    Time frame: 28 days

  2. Total number of patients develop hepatorenal Syndrome.

    Time frame: 1 Year

  3. Total number of patients develop hyponatremia.

    Time frame: 1 Year

  4. Changes in aldosterone with volume of ascitic fluid tap

    Time frame: 1 Year

  5. Changes in plasma renin activity

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2015
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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