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NCT Number: NCT04238416

Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or Hepatic encephalopathy scoring algorithm (HESA)

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

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.

Treatment and study plan

Branched chain amino acid

Drug

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

Lactulose

Drug

Oral lactulose will be given to patients in both arms

Primary outcomes

  1. Improvement of Survival

    Time frame: At day day 28

    All cause Mortality assessment

  2. Improvement of encephalopathy by ≥ 1 grade

    Time frame: 72 hours

    Improvement in hepatic encephalopathy

Secondary outcomes

  1. Reduction in level of ammonia

    Time frame: 48 and 72 hours

  2. Reduction of consciousness recovery time among survivors

    Time frame: 30 days

  3. Prolongation of time to death among non-survivors

    Time frame: 30 days

  4. Prevention/reduction of cerebral edema based on optic nerve sheath diameter

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Efficacy of Lactulose Plus Intravenous Branched Chain Amino Acids Versus Lactulose Alone in Patients of Acute on Chronic Liver Failure With Overt Hepatic Encephalopathy: A Prospective Randomized Clinical Trial

Acronym: BCAA-ACLF

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2020
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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