Therapeutic Efficacy of L-Ornithine L-Aspartate Infusion in Patients With Acute Liver Failure

• Status: Unknown status
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether L-Ornithine L-Aspartate infusion improves the survival of patients with acute liver failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: N-Methylaspartate

Criteria

Inclusion Criteria:

• Patients with acute liver failure, as defined by the development of encephalopathy within 4 weeks of onset of symptoms in the absence of preexisting liver disease.

Exclusion Criteria:

• Presence of > 3 adverse prognostic factors (Age > 40 years, clinical evidence of cerebral edema, bilirubin >15mg/dL, and prothrombin time prolonged by > 25 seconds) at the initial patient evaluation.

• Suspicion of underlying cirrhosis.

• Previous treatment with LOLA or other ammonia lowering treatments before admission.

• Malarial hepatopathy, enteric hepatitis, alcoholic hepatitis, or ischemic hepatitis.

• Active alcohol use of >40 gm/week at the onset of illness.

• Renal insufficiency at admission, as defined by a urine output of <500 mL/d and /or creatinine level of > 3mg/dL.

• Inability to randomize within 24 hours of admission.