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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02467348
Enrollment
80
Registered
2015-06-10
Start date
2015-03-15
Completion date
2017-01-31
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute on Chronic Liver Failure

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

Interventions

DRUGAlbumin

Intravenous albumin 8 gms/L of ascitic fluid

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Total number of patients develop Circulatory Dysfunction because of paracentesis.1 Year

Secondary

MeasureTime frame
Survival28 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 tap1 Year
Changes in plasma renin activity1 year

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026