Effects of Maintaining Steady Albumin Levels (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Liver Cirrhosis

Treatments: Drug: ALB Protein, Human; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04058613

ILBS-TAT4-01

Details and patient eligibility

About

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) with ascites.

Full 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 liver disease and probability of worsening ascites, hepatorenal syndrome with increased risk for infections. Of the three recent RCTs on utility of long-term administration of albumin, two showed improvement in survival. The studies had included different patient populations (diuretic refractory ascites, high dose diuretics and patients on liver transplant waiting list) with different albumin infusion protocols and different end-points. These studies were done in advanced cases of cirrhosis. There is limited data on the utility of regular albumin infusions in early hepatic decompensation (albumin levels-<2.8g/dl with ascites) and the effect of maintaining a targeted albumin level on survival or liver related side effects. Investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation.

Enrollment: 304 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups, including a placebo group

Albumin

Experimental group

Description:

Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy

Treatment:

Drug: ALB Protein, Human

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo