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

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Jan 17, 2023

Keywords

ClinConnect Summary

The BCAA-HE-ACLF clinical trial is exploring the potential benefits of a treatment using intravenous branched-chain amino acids (BCAA) for patients suffering from hepatic encephalopathy (HE) due to acute-on-chronic liver failure (ACLF). This study aims to find out if combining BCAA with a standard medication called lactulose can improve symptoms and help manage the condition better than using lactulose alone. Researchers will also look at how this treatment affects ammonia levels in the body, inflammation, and overall survival rates for participants.

To participate in this trial, individuals must be between 18 and 75 years old and diagnosed with ACLF along with moderate to severe HE. Unfortunately, those with certain medical conditions, like severe heart or kidney problems, recent strokes, or specific infections, won't be eligible. Participants can expect to receive close monitoring and care during the study, contributing to important research that may lead to better treatments for HE in the future.

Gender

ALL

Eligibility 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.