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Recruiting
NCT05700695
Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)
Conditions: Hepatic Encephalopathy, Acute-On-Chronic Liver Failure
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE1
Enrollment: 246
Sponsor: Postgraduate Institute of Medical Education and Research
Location: India
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.
Eligibility Criteria
Inclusion Criteria:Age 18-75 yearsEither genderPatients with ACLF (CANONIC definition) of any etiology with HE ≥grade 2 as per West-Haven CriteriaExclusion Criteria:Those who do not consent to participate in the studyPatients with structural brain lesions or strokeInability to obtain informed consent from patient or relativesSevere preexisting cardiopulmonary diseaseRenal dysfunction (S.
Creatinine ≥ 2mg/dL)Pregnancy/LactationPost liver transplant patientsHIV infectionPatients who are on psychoactive drugs, like sedatives or antidepressantsPatients who are too sick to carry out the protocol.
Source: ClinicalTrials.gov (NCT05700695). StuddyBuddy aggregates publicly available trial information.
