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

Not Applicable

Completed

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Albumin; Drug: Ascitic fluid

• Registration Number: NCT02467348
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-15
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-10
• Status Verified: 2017-01
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Last Update Submitted: 2017-11-25
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin	Ascitic fluid	MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.
No Albumin	Ascitic fluid	MVP (Modest Volume Paracentesis) of less than 5 litres without albumin.
Albumin	Albumin	MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.

Primary Outcome Measures

Name	Time	Method
Total number of patients develop Circulatory Dysfunction because of paracentesis.	1 Year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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