Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients With Acute Decompensation of Cirrhosis

NCT05956197 | Unknown

• 1 other identifier: ILBS-Cirrhosis-50
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Research Objectives- We hypothesized high-dose 25% albumin would be superior to standard medical treatment in improving 3-month mortality in patients with acute decompensation of cirrhosis by improving the systemic hemodynamics and amelioration of systemic inflammation, endothelial function and coagulation. Aim: To study the efficacy of 25% albumin in reducing 3-month mortality in acute decompensation in cirrhosis. Primary Objective

• To study the efficacy of 25% albumin in reducing the 3-month mortality. Secondary Objectives
• To study the cumulative incidence of liver related complications (paracentesis induced circulatory dysfunction (PICD), AKI, hyponatremia, hepatic encephalopathy and variceal bleed)
• Improvement in MELD, CTP, SOFA and AARC scores
• Impact on cardiac function and systemic hemodynamics
• Impact of albumin on development of SBP and non-SBP infections
• Survival free of liver transplant and TIPS at 3 months
• Effect of albumin therapy on immunomodulation, dysfunctional albumin, endothelial function and coagulation at 3 months
• Proportion of patients achieving recompensation at 3 months
• Time to achieve serum albumin \>4 g/dL and its correlation with clinical outcomes.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Overall mortality.

  3 months

Secondary Outcomes (22)

• Incidence of liver-related complications.

  1 month

• Incidence of liver-related complications.

  3 months

• Survival free of liver transplant and TIPS in both groups.

  1 month

• Survival free of liver transplant and TIPS in both groups.

  3 months

• Delta change in the mean arterial pressure in mm of Hg before and after albumin.

  1 month

Study Arms (1)

Acute Decompensation of Cirrhosis

Acute Decompensation of Cirrhosis

Other: No intervention

Interventions

No intervention OTHER

No intervention. This is a cohort study

Acute Decompensation of Cirrhosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute decompensation of cirrhosis

You may qualify if:

• Patients with acute decompensation of cirrhosis
• Patients with age from 18-65 years

You may not qualify if:

• Recent Gastrointestinal bleeding within 7 days
• 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
• Pregnancy
• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Central Study Contacts

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: July 21, 2023
• Study Start: July 25, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

IN (1)