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

Acute on Chronic Liver Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467348
• Other study ID #: ILBS-ACLF and Cirrhosis-01
• Status: Completed
• Phase: N/A
• First received: June 4, 2015
• Last updated: November 25, 2017
• Start date: March 15, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: January 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Drug:
• Albumin
Intravenous albumin 8 gms/L of ascitic fluid
• Ascitic fluid

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of patients develop Circulatory Dysfunction because of paracentesis.		1 Year
Secondary	Survival		28 days
Secondary	Total number of patients develop hepatorenal Syndrome.		1 Year
Secondary	Total number of patients develop hyponatremia.		1 Year
Secondary	Changes in aldosterone with volume of ascitic fluid tap		1 Year
Secondary	Changes in plasma renin activity		1 year