CompletedPhase 1

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

India114 participantsStarted 2023-01-17

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

Survival

Timeframe: Day 28

Trial details

NCT IDNCT05700695

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-05

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