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

Last updated: June 5, 2025
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Overall Status: Completed

Phase

1

Condition

Liver Disorders

Liver Disease

Neurologic Disorders

Treatment

Branch Chain Amino Acid

Lactulose

Clinical Study ID

NCT05700695
IEC/04/2022-2385
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75 years

  2. Either gender

  3. Patients with ACLF (CANONIC definition) of any etiology with HE ≥grade 2 as perWest-Haven Criteria

Exclusion

Exclusion Criteria:

  1. Those who do not consent to participate in the study

  2. Patients with structural brain lesions or stroke

  3. Inability to obtain informed consent from patient or relatives

  4. Severe preexisting cardiopulmonary disease

  5. Renal dysfunction (S. Creatinine ≥ 2mg/dL)

  6. Pregnancy/Lactation

  7. Post liver transplant patients

  8. HIV infection

  9. Patients who are on psychoactive drugs, like sedatives or antidepressants

  10. Patients who are too sick to carry out the protocol.

Study Design

Total Participants: 114
Treatment Group(s): 2
Primary Treatment: Branch Chain Amino Acid
Phase: 1
Study Start date:
January 17, 2023
Estimated Completion Date:
June 05, 2025

Study 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.

Connect with a study center

  • Dr. Madhumita Premkumar

    Chandigarh, 160012
    India

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.