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Plasmapheresis plus LOLA in liver failure of children.

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: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049867
Enrollment
32
Registered
2023-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K720- Acute and subacute hepatic failure

Interventions

Intervention1: L-ornithine L-Aspartate: 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 volu

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pediatric Acute Liver Failure as defined by PALF-Study Group 2. 5-18 years of age 3. INR > 2 4. Hepatic encephalopathy (defined by West Haven criteria) 5. Ammonia >100mcg/dL

Exclusion criteria

Exclusion criteria: 1. Irreversible neurological injury 2. Previous treatment with LOLA within 48 hours before admission. 3. Acute kidney injury. 4. Acute on chronic liver failure 5. Those not giving consent

Design outcomes

Primary

MeasureTime frame
Comparison of change in ammonia (baseline to day 3) in the 2 groupsTimepoint: 72 hrs—

Secondary

MeasureTime frame
Compare the adverse events in the 2 groupsTimepoint: 72 hours;Comparison of improvement in grade of encephalopathyTimepoint: Day 3 and day 7;Comparison of number of episodes of clinically raised intracranial pressure in the 2 groupsTimepoint: 72 hours;Comparison of ONSDTimepoint: 24,48 and 72 hours;Comparison of overall survivalTimepoint: Day 7 and Day 14;Comparison of plasma and dialysate glutamine levels after HVPETimepoint: 72 hours;Comparison of survival with native liver.Timepoint: Day 7 and Day 14;To compare the cumulative requirement of mannitol and propofol in the first 72 hoursTimepoint: 72 hr—

Countries

India

Contacts

Public ContactDr Bikrant Bihari Lal

Institute of Liver and Biliary Sciences

bikrant18may@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026