Using intravenous branched-chain amino acids to treat hepatic encephalopathy in liver failure patients
Intravenous Branched-chain Amino Acids for Overt Hepatic Encephalopathy in Patients With Acute on Chronic Liver Failure - A Multi-centric Double-blind Randomized Controlled Trial
PHASE1 · Post Graduate Institute of Medical Education and Research, Chandigarh · NCT05700695
This study tests whether giving intravenous branched-chain amino acids along with lactulose can help people with liver failure and severe confusion feel better and improve their health compared to just using lactulose alone.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh (other) |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT05700695 on ClinicalTrials.gov |
What this trial studies
This multi-centric clinical trial investigates the effects of intravenous branched-chain amino acids (BCAA) on patients suffering from overt hepatic encephalopathy (HE) due to acute-on-chronic liver failure (ACLF). The study compares the efficacy of BCAA combined with lactulose against lactulose alone, focusing on ammonia levels, systemic inflammation, and cerebral edema. Additionally, it aims to assess overall survival rates and improvements in HE severity. The trial is designed to fill a gap in existing research regarding the adjuvant effects of intravenous BCAA in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with ACLF and hepatic encephalopathy of grade 2 or higher.
Not a fit: Patients with severe preexisting conditions, structural brain lesions, or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of hepatic encephalopathy in patients with acute-on-chronic liver failure.
How similar studies have performed: While the use of BCAA in liver disease has been explored, this specific approach of intravenous BCAA for HE in ACLF is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chandigarh
- Dr. Madhumita Premkumar — Chandigarh, India (RECRUITING)
Study contacts
- Study coordinator: Dr Madhumita Premkumar, DM
- Email: drmadhumitap@gmail.com
- Phone: 7087003409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatic Encephalopathy, Acute-On-Chronic Liver Failure, Neurological Dysfunction, Metabolomics, Systemic Inflammations, Branch Chain Amino Acid, bispectral index, Cerebral edema