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

NCT ID: NCT04058613

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2021-08-08

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) with ascites.

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 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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Albumin

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

Group Type: EXPERIMENTAL

ALB Protein, Human

Intervention Type: DRUG

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo

Interventions

ALB Protein, Human

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

Intervention Type: DRUG

placebo

placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Shasthry SM

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr Shasthry SM, MD

Role: CONTACT

shasthry@gmail.com

01146300000

Facility Contacts

Dr Shasthry SM, MD

Role: primary

shasthry@gmail.com

01146300000

Other Identifiers

ILBS-TAT4-01

Identifier Type: -

Identifier Source: org_study_id