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

Post Graduate Institute of Medical Education and Research, Chandigarh114 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

114

Conditions

Hepatic Encephalopathy Acute-On-Chronic Liver Failure

Interventions

Branch Chain Amino AcidDRUG

Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm

LactuloseDRUG

Oral lactulose will be given to patients in both arms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dr. Madhumita Premkumar

Chandigarh, Chandigarh, India

Outcomes

Primary Outcomes

Survival

Survival assessment will be made by recording all deaths

Time frame: Day 28

Secondary Outcomes

Reduction of arterial ammonia Level

Level of ammonia will be measured by Point of care device

Time frame: Day 3

Reduction of arterial ammonia Level

Level of ammonia will be measured by Point of care device

Time frame: Day 7

Assessment of cerebral edema

Cerebral edema will be assessed by Magnetic Resonance Imaging+ Magnetic Resonance Spectroscopy

Time frame: Discharge form Hospital and 3 month of episode of HE

Prevention/reduction of cerebral edema based on optic nerve sheath diameter (ONSD)

ONSD measurement will be done by Ultrasound

Time frame: 72 Hours

Reduction of consciousness recovery time among survivors

Consciousness will be assessed by cognitive battery tests

Time frame: Day 28

Survival

Survival assessment will be done with recording all cause mortality

Time frame: Day 28

Survival

Survival assessment will be done with recording all cause mortality

Time frame: Day 90

Improvement of encephalopathy by one or more grade

Data from ClinicalTrials.gov

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