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

• Status: Recruiting
• Trial end date: 2025-04-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborators: All India Institute of Medical Sciences, Bhubaneswar; Amrita Institute of Medical Sciences & Research Center; Asian Institute of Gastroenterology, India; Kalinga Institute of Medical Sciences, Bhubaneswar
• Treatments: Lactulose

Criteria

Inclusion Criteria:

1. Age 18-75 years

2. Either gender

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

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.