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.

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT02467322
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Decompensated Cirrhosis	Drug: Albumin; Drug: ascitic fluid	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Feb 23, 2015
• Actual Primary Completion Date: Dec 15, 2016
• Actual Study Completion Date: Dec 15, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of PICD (Paracentesis Induced Circulatory Dysfunction). [1 Year]

Secondary Outcome Measures

1. Survival [28 days]

2. Total number of patients develop Hepatorenal Syndrome. [1 Year]

3. Total number of patients develop hyponatremia. [1 Year]

4. Changes in plasma Renin activity. [1 Year]

5. Changes in aldosterone with volume of ascitic fluid tap. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT02467322
• Other Study ID Numbers: ILBS-Cirrhosis-003
• First Posted: Jun 10, 2015
• Last Update Posted: Jun 12, 2017
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Fibrosis

Study Results

No Results Posted as of Jun 12, 2017