Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)

Status Recruiting

Clinical Trial Summary

This multi-centric study analyses the effect of intravenous branched-chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators aim to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone, ammonia measures, endotoxin, metabolomics, and cerebral edema in the medical management of overt HE in patients with ACLF. The study will also access the impact on overall survival and improvement in the grade of HE.

Clinical Trial Description

Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients with HE. The mainstay of treatment remains Lactulose. Rifaximin is added on to therapy who have a breakthrough episode of HE on lactulose. BCAA is used as an add-on therapy if patients have minimal/covert encephalopathy, are protein intolerant or have recurrent HE. No studies are available assessing the adjuvant effect of intravenous BCAA on ammonia reduction in HE in patients with ACLF. So, this study has been designed to analyze the effect of intravenous BCAA on hepatic encephalopathy in patients with ACLF. This study will also analyze the systemic and neuronal inflammation, metabolomics, and cerebral edema under the effect of intravenous BCAA in HE patients with ACLF. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05700695
Study type	Interventional
Source	Post Graduate Institute of Medical Education and Research, Chandigarh
Contact	Dr Madhumita Premkumar, DM
Phone	7087003409
Email	drmadhumitap@gmail.com
Status	Recruiting
Phase	Phase 1
Start date	January 17, 2023
Completion date	April 25, 2025

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See also
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