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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02467348
Other study ID # ILBS-ACLF and Cirrhosis-01
Secondary ID
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
Health authority
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

Study Design


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
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