Status:
UNKNOWN
Therapeutic Efficacy of L-Ornithine L-Aspartate Infusion in Patients With Acute Liver Failure
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Acute Liver Failure
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether L-Ornithine L-Aspartate infusion improves the survival of patients with acute liver failure.
Detailed Description
Acute liver failure (ALF) has a high mortality. However, those who survive recover completely without any sequel. Liver transplantation is logistically and financially difficult in most countries with...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00470314
Start Date
January 1 2005
End Date
May 1 2007
Last Update
January 7 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
All India Institute of Medical Sciences
Delhi, India