Efficacy of L-ornithine L-aspartate and Therapeutic Plasma Exchange Versus Plasma Exchange Alone in Lowering Ammonia and Improving Outcomes in Pediatric Acute Liver Failure.
Liver Failure, Acute
About this trial
This is an interventional treatment trial for Liver Failure, Acute
Eligibility Criteria
Inclusion Criteria: Pediatric Acute Liver Failure as defined by PALF-Study Group 5-18 years of age INR > 2 Hepatic encephalopathy (defined by West Haven criteria) Ammonia >100mcg/dL Exclusion Criteria: Irreversible neurological injury Previous treatment with LOLA within 48 hours before admission. Acute kidney injury. Acute on chronic liver failure Those not giving consent
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
L-ornithine L-Aspartate
Placebo
LOLA will be administered via continuous intravenous infusion at a dosage of 0.75g/kg/day for 72h (maximum 30g/day). High volume plasma exchange (2x plasma volume) will be started at least 8 hours after initiation of LOLA, and will be completed within 4-5 hours depending on the volume of exchange. Three consecutive cycles of HVPE will be performed, starting at 8h, 32h and 56h respectively.
Placebo will be administered via continuous infusion for 72h, along with HVPE (2x plasma volume) starting at 8h, 32h and 56h respectively.