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Completed

NCT Number: NCT02467322

To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics 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. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .

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Key information

Conditions

Decompensated Cirrhosis

Age range

18 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 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

MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.

ascitic fluid

Drug

Primary outcomes

  1. Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).

    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 plasma Renin activity.

    Time frame: 1 Year

  5. Changes in aldosterone with volume of ascitic fluid tap.

    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 Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2015
Registry last updated
Jun 12, 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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