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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01559519` - Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy	Phase 4
Terminated	`NCT01846806` - The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.	N/A
Recruiting	`NCT01178372` - Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis	Phase 4
Completed	`NCT00914056` - A Study of Controlled Lactulose Withdrawal	N/A
Completed	`NCT00740142` - Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy	Phase 4
Completed	`NCT00558038` - Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy	Phase 2
Completed	`NCT00986895` - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group	Phase 1
Completed	`NCT00287235` - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)	N/A
Recruiting	`NCT05539027` - Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy	Phase 4
Recruiting	`NCT04096014` - Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy	N/A
Completed	`NCT05526404` - Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration	N/A
Completed	`NCT04082780` - Rifamycin in Minimal Hepatic Encephalopathy	Phase 2
Enrolling by invitation	`NCT06367127` - Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Active, not recruiting	`NCT05425316` - Speech in Hepatic Encephalopathy (HE)
Recruiting	`NCT04415294` - Flicker App for Minimal Hepatic Encephalopathy
Not yet recruiting	`NCT06072521` - Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy	Phase 2
Withdrawn	`NCT02086825` - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure	Phase 3
Completed	`NCT02636647` - Fecal Transplant in Recurrent Hepatic Encephalopathy	Phase 1
Completed	`NCT01446523` - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE	N/A
Completed	`NCT01218568` - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial	N/A