Status:
UNKNOWN
Effects of Maintaining Steady Albumin Levels (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (\<2.8g/dl) ...
Detailed Description
Cirrhosis is characterized by progressive deterioration in liver functions. Liver's synthetic functions are inferred by serum albumin and INR estimation. Lower albumin level is a marker of severe live...
Eligibility Criteria
Inclusion
- Newly detected cirrhotic patients aged more than 18 years
- Cirrhosis defined by standard clinical, analytical and/or histological criteria
- Serum albumin level \< 2.8g/dl with or without ascites
- Who would agree to give written informed consent
Exclusion
- Uncontrolled HTN (sys\>150/ dis \>90 mmHg) or h/o any drug therapy for HTN
- Prior h/o Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Hepatocellular Carcinoma
- Active alcohol abuse within 3 months
- Patients presenting as Acute on Chronic Liver Failure
- Extrahepatic organ failure
- Known case of chronic heart failure or respiratory failure
- Diagnosed Chronic Kidney Disease
- Patients with hydrothorax
- Prior liver transplant recipient
- Human Immunodeficiency Virus infection
- Use of albumin infusion in the last one month
- CTP\>12, MELD\>28
- Total Bilirubin \>3 g/dl
- Overt Hepatic Encephalopathy at Presentation
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 8 2021
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT04058613
Start Date
September 10 2019
End Date
August 8 2021
Last Update
September 12 2019
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070