A Phase 1 interventional study of Branch Chain Amino Acid and Lactulose in Hepatic Encephalopathy and Acute-On-Chronic Liver Failure, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 1, Interventional, and Treatment
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.
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.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's enrollment of 114 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
Drug: iv Branch Chain Amino Acid + Lactulose Intravenous Branched Chain Amino Acids - 500mL once daily for 3 days plus Lactulose
Drug: Branch Chain Amino Acid · Drug: Lactulose
Drug: Lactulose + Placebo of IV BCAA solution
Drug: Lactulose
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
Survival
Survival assessment will be made by recording all deaths
Time frame: Day 28
Reduction of arterial ammonia Level
Level of ammonia will be measured by Point of care device
Time frame: Day 3
Reduction of arterial ammonia Level
Level of ammonia will be measured by Point of care device
Time frame: Day 7
Assessment of cerebral edema
Cerebral edema will be assessed by Magnetic Resonance Imaging+ Magnetic Resonance Spectroscopy
Time frame: Discharge form Hospital and 3 month of episode of HE
Prevention/reduction of cerebral edema based on optic nerve sheath diameter (ONSD)
ONSD measurement will be done by Ultrasound
Time frame: 72 Hours
Reduction of consciousness recovery time among survivors
Consciousness will be assessed by cognitive battery tests
Time frame: Day 28
Survival
Survival assessment will be done with recording all cause mortality
Time frame: Day 28
Survival
Survival assessment will be done with recording all cause mortality
Time frame: Day 90
Improvement of encephalopathy by one or more grade
Improvement in scoring of hepatic Encephalopathy
Time frame: Day 7
Assessment of metabolomics following BCAA + Lactulose and Lactulose alone
Metabolomics will be performed by LC/GC-MS
Time frame: Day 7
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.
Systemic inflammation will be accessed by Cytometric Bead Array
Time frame: Day 0
Plan to share: No
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh