Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.
NCT ID: NCT02467348
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-03-15
2017-01-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Albumin
MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.
Albumin
Intravenous albumin 8 gms/L of ascitic fluid
Ascitic fluid
No Albumin
MVP (Modest Volume Paracentesis) of less than 5 litres without albumin.
Ascitic fluid
Interventions
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Albumin
Intravenous albumin 8 gms/L of ascitic fluid
Ascitic fluid
Eligibility Criteria
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Inclusion Criteria
2. All Cirrhotics decompensated with ascites admitted in the hospital.
3. Grade II/III ascites
4. Need for paracentesis.
Exclusion Criteria
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
12 Years
75 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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References
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Arora V, Vijayaraghavan R, Maiwall R, Sahney A, Thomas SS, Ali R, Jain P, Kumar G, Sarin SK. Paracentesis-Induced Circulatory Dysfunction With Modest-Volume Paracentesis Is Partly Ameliorated by Albumin Infusion in Acute-on-Chronic Liver Failure. Hepatology. 2020 Sep;72(3):1043-1055. doi: 10.1002/hep.31071. Epub 2020 Jul 9.
Other Identifiers
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ILBS-ACLF and Cirrhosis-01
Identifier Type: -
Identifier Source: org_study_id