Status:
UNKNOWN
Efficacy of Targeted And Response-Guided Albumin Therapy Versus Standard Medical Treatment In Outcomes Of Recurrent Ascites In Patients With Decompensated Cirrhosis.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Decompensated Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The current prospective randomized controlled trial would aim to study the efficacy of targeted albumin therapy versus standard medical treatment in reduction in 6-month mortality in recurrent ascites...
Detailed Description
Study Design Aim \& Objectives Primary • To study the efficacy of targeted albumin therapy versus standard medical treatment in reduction in 6-month mortality in recurrent ascites in patients with de...
Eligibility Criteria
Inclusion
- Patients with cirrhosis of liver with recurrent ascites.
- Patients with age from 18-70 years
Exclusion
- Renal failure (Creatinine \>1.5mg/dl)
- Recent Gastrointestinal bleeding within 7 days
- Spontaneous bacterial Peritonitis
- Patients with organic nephropathy ( as defined by IAC)
- Patients with Cardiovascular disease or chronic obstructive pulmonary disease
- Systemic arterial hypertension (\>160/90mmhg)
- Presence of hepatocellular carcinoma (outside Milan criteria)( or portal vein thrombosis
- Budd-Chiari Syndrome
- Patients with active sepsis
- Pregnancy
- Patients with hepatic encephalopathy
- No use of drugs affecting systemic hemodynamics 7 days prior to enrolment (except beta-blockers)
- Patients with serum albumin \>3 gm
- Refusal to participate
- Known or suspected hypersensitivity to albumin
- Prior TIPS
- Post liver or kidney transplantation
- Patients enrolled in other clinical trials
- Extrahepatic malignancy
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04679571
Start Date
December 30 2020
End Date
September 30 2022
Last Update
December 22 2020
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070