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Search / Trial NCT05956197

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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Jul 12, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a high-dose albumin treatment on patients who have severe liver problems known as acute decompensation of cirrhosis. The main goal is to see if giving 25% albumin can help reduce the risk of death within three months compared to standard treatments. The researchers believe that this treatment might improve blood flow and reduce inflammation, which could lead to better overall health and fewer complications related to liver issues.

To participate in the trial, patients need to be between 18 and 65 years old and diagnosed with acute decompensation of cirrhosis. However, certain conditions could prevent someone from joining, such as recent gastrointestinal bleeding, certain heart or kidney diseases, high blood pressure, or cancer. If eligible, participants will receive the albumin treatment and be monitored for improvements in their health over three months, including their liver function and overall survival without needing a liver transplant. It's important to note that this trial is not yet recruiting participants, so those interested will need to wait for it to begin.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with acute decompensation of cirrhosis
  • Patients with age from 18-65 years
  • Exclusion Criteria:
  • 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

About Institute Of Liver And Biliary Sciences, India

The Institute of Liver and Biliary Sciences (ILBS) in India is a premier research and healthcare institution dedicated to the advancement of knowledge and treatment in liver, biliary, and related diseases. As a clinical trial sponsor, ILBS is committed to conducting innovative and ethically-driven research to improve patient outcomes and enhance therapeutic options in hepatology. The institute fosters collaboration among multidisciplinary teams of clinicians, researchers, and healthcare professionals, ensuring rigorous scientific methodologies and adherence to regulatory standards. Through its focus on translational research, ILBS aims to bridge the gap between laboratory discoveries and clinical applications, ultimately contributing to the global understanding and management of liver diseases.

Locations

New Delhi, Delhi, India

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported