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

Sponsored by:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00470314

Purpose

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

Condition	Intervention	Phase
Acute Liver Failure	Drug: L-Ornithine L-Aspartate	Phase II

Drug Information available for: Aspartic acid Ornithine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Therapeutic Efficacy of L-Ornithine L-Aspartate Infusion in Patients With Acute Liver Failure: A Double- Blind, Randomized, Placebo- Controlled Study

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

Improvement in survival. [ Time Frame: Within 30 days of disease onset ]

Secondary Outcome Measures:

Reduction in ammonia levels during and at the end of 72 hour LOLA infusion. [ Time Frame: 72 hours ]
Improvement of encephalopathy by one or more grades. [ Time Frame: 72 hours ]
Reduction of consciousness recovery time (CRT) among survivors. [ Time Frame: Within 30 days of disease onset ]
Prolongation of time to death among non-survivors. [ Time Frame: Within 30 days of disease onset ]
Prevention / reduction of cerebral edema. [ Time Frame: 72 hours ]
Reduction of seizures frequency. [ Time Frame: Within 30 days of disease onset ]

Enrollment:	150
Study Start Date:	January 2005
Estimated Study Completion Date:	May 2007

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470314

Locations

India
All India Institute of Medical Sciences
Delhi, India

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

Study Director:	Subrat Kr Acharya, M.D., D.M.	All India Institute of Medical Sciences, New Delhi
Principal Investigator:	Vikram Bhatia, M.D., D.M.	All India Institute of Medical Sciences, New Delhi
Principal Investigator:	Amit Singhal, M.D.	All India Institute of Medical Sciences, New Delhi

More Information

Additional Information:

An easy to navigate site providing overview of liver failure, and treatment options This link exits the ClinicalTrials.gov site

Comprehensive details of liver failure in the pediatric population This link exits the ClinicalTrials.gov site

Publications:

Bhatia V, Singh R, Acharya SK. Predictive value of arterial ammonia for complications and outcome in acute liver failure. Gut. 2006 Jan;55(1):98-104. Epub 2005 Jul 15.

Clemmesen JO, Larsen FS, Kondrup J, Hansen BA, Ott P. Cerebral herniation in patients with acute liver failure is correlated with arterial ammonia concentration. Hepatology. 1999 Mar;29(3):648-53.

Staedt U, Leweling H, Gladisch R, Kortsik C, Hagmuller E, Holm E. Effects of ornithine aspartate on plasma ammonia and plasma amino acids in patients with cirrhosis. A double-blind, randomized study using a four-fold crossover design. J Hepatol. 1993 Nov;19(3):424-30.

Kircheis G, Nilius R, Held C, Berndt H, Buchner M, Gortelmeyer R, Hendricks R, Kruger B, Kuklinski B, Meister H, Otto HJ, Rink C, Rosch W, Stauch S. Therapeutic efficacy of L-ornithine-L-aspartate infusions in patients with cirrhosis and hepatic encephalopathy: results of a placebo-controlled, double-blind study. Hepatology. 1997 Jun;25(6):1351-60.

Rose C, Michalak A, Rao KV, Quack G, Kircheis G, Butterworth RF. L-ornithine-L-aspartate lowers plasma and cerebrospinal fluid ammonia and prevents brain edema in rats with acute liver failure. Hepatology. 1999 Sep;30(3):636-40.

Study ID Numbers:	GE-LOLA/2005
Study First Received:	May 4, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00470314 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:

Acute liver failure
Ornithine Aspartate
Ammonia
Encephalopathy

Study placed in the following topic categories:

Excitatory Amino Acids
Liver Failure
Neurotransmitter Agents
Liver Diseases

Digestive System Diseases
Liver Failure, Acute
N-Methylaspartate
Hepatic Insufficiency

Additional relevant MeSH terms:

Liver Failure
Neurotransmitter Agents
Liver Diseases
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Agonists

Liver Failure, Acute
Physiological Effects of Drugs
Excitatory Amino Acid Agents
N-Methylaspartate
Pharmacologic Actions
Hepatic Insufficiency

ClinicalTrials.gov processed this record on May 07, 2009