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

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    68
  • sponsor
    Postgraduate Institute of Medical Education and Research
Updated on 24 February 2022
lactulose
encephalopathy
branched chain amino acids
amino acids

Summary

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.

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.

Details
Condition Hepatic Encephalopathy, Acute-On-Chronic Liver Failure
Treatment Lactulose, Branched chain amino acid
Clinical Study IdentifierNCT04238416
SponsorPostgraduate Institute of Medical Education and Research
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-75 years
Either gender
Patients with ACLF (CANONIC definition) of any aetiology with HE grade 2 as per West-Haven Criteria

Exclusion Criteria

Those who do not consent to participate in the study
Patients with structural brain lesions or stroke
Inability to obtain informed consent from patient or relatives
Severe preexisting cardiopulmonary disease
Renal dysfunction (S. Creatinine 2mg/dL)
Pregnancy/Lactation
Post liver transplant patients
HIV infection
Patients who are on psychoactive drugs, like sedatives or antidepressants
Patients who are too sick to carry out the protocol
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