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NCT Number: NCT05700695

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

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.

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Key information

Conditions

Hepatic Encephalopathy Acute-On-Chronic Liver Failure Brain Diseases Brain Diseases, Metabolic Brain Edema Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Madhumita Premkumar

Chandigarh, 160012, India

About this study

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.

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 etiology 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.

Treatment and study plan

Branch 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. Survival

    Time frame: Day 28

    Survival assessment will be made by recording all deaths

Secondary outcomes

  1. Reduction of arterial ammonia Level

    Time frame: Day 3

    Level of ammonia will be measured by Point of care device

  2. Reduction of arterial ammonia Level

    Time frame: Day 7

    Level of ammonia will be measured by Point of care device

  3. Assessment of cerebral edema

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

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

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

    Time frame: 72 Hours

    ONSD measurement will be done by Ultrasound

  5. Reduction of consciousness recovery time among survivors

    Time frame: Day 28

    Consciousness will be assessed by cognitive battery tests

  6. Survival

    Time frame: Day 28

    Survival assessment will be done with recording all cause mortality

  7. Survival

    Time frame: Day 90

    Survival assessment will be done with recording all cause mortality

  8. Improvement of encephalopathy by one or more grade

    Time frame: Day 7

    Improvement in scoring of hepatic Encephalopathy

  9. Assessment of metabolomics following BCAA + Lactulose and Lactulose alone

    Time frame: Day 7

    Metabolomics will be performed by LC/GC-MS

  10. Dynamic Assessment of systemic inflammation (Cytokines: IL-1b, IL-6, INF-g, TNF-a, IL-15, IL-17, IL-18) at presentation and after Specific management.

    Time frame: Day 0

    Systemic inflammation will be accessed by Cytometric Bead Array

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar
  • Amrita Institute of Medical Sciences & Research Center
  • Asian Institute of Gastroenterology, India
  • Kalinga Institute of Medical Sciences, Bhubaneswar

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2023
Registry last updated
Jun 8, 2025

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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