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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm
Oral lactulose will be given to patients in both arms
PGIMER
Chandigarh, India
Improvement of Survival
All cause Mortality assessment
Time frame: At day day 28
Improvement of encephalopathy by ≥ 1 grade
Improvement in hepatic encephalopathy
Time frame: 72 hours
Reduction in level of ammonia
Time frame: 48 and 72 hours
Reduction of consciousness recovery time among survivors
Time frame: 30 days
Prolongation of time to death among non-survivors
Time frame: 30 days
Prevention/reduction of cerebral edema based on optic nerve sheath diameter
Time frame: 72 hours
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