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.

Not Applicable

Completed

• Conditions: Decompensated Cirrhosis
• Interventions: Drug: Albumin; Drug: ascitic fluid

• Registration Number: NCT02467322
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-06
• Study First Posted: 2015-06-10
• Status Verified: 2016-10
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. All Cirrhotics decompensated with ascites admitted in the hospital.
2. Grade II/III ascites
3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin	Albumin	MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid.
Albumin	ascitic fluid	MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid.
No Albumin	ascitic fluid	MVP(Moderate Volume Paracentesis) of less than 5 liters without albumin.

Primary Outcome Measures

Name	Time	Method
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).	1 Year

Secondary Outcome Measures

Name	Time	Method
Survival	28 days
Changes in aldosterone with volume of ascitic fluid tap.	1 year
Total number of patients develop Hepatorenal Syndrome.	1 Year
Total number of patients develop hyponatremia.	1 Year
Changes in plasma Renin activity.	1 Year

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India