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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT02467348
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.6
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute on Chronic Liver Failure	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 Acute-On-Chronic Liver Failure Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
• Actual Study Start Date: Mar 15, 2015
• Actual Primary Completion Date: Jan 31, 2017
• Actual Study Completion Date: Jan 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Albumin MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.	Drug: Albumin; Intravenous albumin 8 gms/L of ascitic fluid; Drug: Ascitic fluid
Active Comparator: No Albumin MVP (Modest Volume Paracentesis) of less than 5 litres without albumin.	Drug: Ascitic fluid

Outcome Measures

Primary Outcome Measures

1. Total number of patients develop Circulatory Dysfunction because of paracentesis. [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 aldosterone with volume of ascitic fluid tap [1 Year]

5. Changes in plasma renin activity [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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: NCT02467348
• Other Study ID Numbers: ILBS-ACLF and Cirrhosis-01
• First Posted: Jun 10, 2015
• Last Update Posted: Nov 28, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure

Study Results

No Results Posted as of Nov 28, 2017