CompletedPhase 1

Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF

India70 participantsStarted 2019-11-01

Plain-language 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.

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 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

What they're measuring

Improvement of Survival

Timeframe: At day day 28

Improvement of encephalopathy by ≥ 1 grade

Timeframe: 72 hours

Trial details

NCT IDNCT04238416

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-30

View on ClinicalTrials.gov More Hepatic Encephalopathy trials