NCT04238416

Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF

Efficacy of Lactulose Plus Intravenous Branched Chain Amino Acids Versus Lactulose Alone in Patients of Acute on Chronic Liver Failure With Overt Hepatic Encephalopathy: A Prospective Randomized Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators plan to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients with ACLF and its impact on overall survival and improvement in grade of HE.

Detailed description

Acute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE) is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients. No studies have compared different treatment options for HE in patients with ACLF.

Conditions

• Hepatic Encephalopathy
• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	Branched chain amino acid	Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm
DRUG	Lactulose	Oral lactulose will be given to patients in both arms

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-01-23
• Last updated: 2022-08-16

Locations

1 site across 1 country: India