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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Acute on Chronic Liver Failure

Intervention / Treatment
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* Drug: Albumin
* Drug: Ascitic fluid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. All Cirrhotics decompensated with ascites admitted in the hospital. Grade II/III ascites Need for paracentesis. Exclusion Criteria: Age <12 or > 75 years Hepatocellular carcinoma Non cirrhotic ascites such as malignancy or tubercular peritonitis Serum Cr >1.5mg% Refractory septic shock Grade III/IV hepatic encephalopathy Abdominal wall cellulitis Active variceal bleed Respiratory, cardiac and renal failure Refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of patients develop Circulatory Dysfunction because of paracentesis. |  | 1 Year | 

Secondary Outcome Measures

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