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.

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 .

Study Overview

• Status: Completed
• Conditions: Decompensated Cirrhosis
• Intervention / Treatment: Drug: Albumin; Drug: ascitic fluid

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin; MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid.	Drug: Albumin; MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.; Drug: ascitic fluid
Active Comparator: No Albumin; MVP(Moderate Volume Paracentesis) of less than 5 liters without albumin.	Drug: ascitic fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).	1 Year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2015
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 6, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: ILBS-Cirrhosis-003