Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF (BCAA-ACLF)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 1

Conditions: Acute-On-Chronic Liver Failure; Hepatic Encephalopathy

Treatments: Drug: Branched chain amino acid; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT04238416

IEC-08/2019-1336

Details and patient eligibility

About

This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators plan to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients with ACLF and its impact on overall survival and improvement in grade of HE.

Full description

Acute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE) is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients. No studies have compared different treatment options for HE in patients with ACLF.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-75 years
2. Either gender
3. Patients with ACLF (CANONIC definition) of any aetiology with HE ≥grade 2 as per West-Haven Criteria or Hepatic encephalopathy scoring algorithm (HESA)

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

As the study was carried out during the peak of the COVID-19, patients who developed COVID-19 after randomization were excluded from the analysis as they were shifted to dedicated COVID-19 ICU's.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

IV BCAA + Lactulose

Experimental group

Description:

IV Branched Chain Amino Acids - 500mL once daily for 3 days plus Lactulose

Treatment:

Drug: Branched chain amino acid

Drug: Lactulose

Lactulose alone

Active Comparator group

Description:

Oral Lactulose alone

Treatment:

Drug: Lactulose