L-ornithine L-aspartate (6 ampules, each ampule containing 5 grams of the drug in 10 ml solution) to be diluted in 440 ml of Dextrose 5% (to make a total of 500 ml of solution), as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo (sterile water, 6 ampuoles of 10 ml each) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Cirrhosis of Liver

Hepatic Encephalopathy

L-ornithine L-aspartate

Placebo (sterile water, 60 ml) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo

Department of Gastroenterology, D.M.C. and Hospital

G.B. Pant Hospital

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Efficacy of Intravenous 'L-ornithine L-aspartate' in Reversal of Overt Acute Hepatic Encephalopathy in Patients With Liver Cirrhosis: a Prospective, Randomized, Double-blind, Placebo Controlled Trial

Mental state grade according to West Haven criteria for Hepatic encephalopathy

Change in blood ammonia levels will be measured at baseline and after 5 days of treatment

Mortality rate in the two groups at 4 weeks will be compared

The total length of hospital stay (number of days) in each group will be compared.

Change in serum cytokine levels (Interleukin-1, Interleukin-6, Interleukin-10 and TNF-alpha will be measured at baseline and after 5 days of treatment.

Prof. Sandeep S Sidhu

Professor

Dayanand Medical College and Hospital

Interventional arm: oral L-ornithine-L-aspartate and oral lactulose

L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days

L-ornithine-L-aspartate and lactulose

placebo and lactulose

Siriraj Hospital, Mahidol University

Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy

Siwaporn Chainuvati

Mahidol University

Brain Diseases, Metabolic, Inborn

Amino Acid Metabolism, Inborn Errors

Urea Cycle Disorders

University of California, Los Angeles

University of California San Francisco

Stanford University Medical Center

Children's Hospital Colorado

Children's National Medical Center

Children's Hospital Boston (UCDC New England Center)

University of Minnesota

Icahn School of Medicine at Mount Sinai

Case Western Medical College

Oregon Health and Science University

Children's Hospital of Philadelphia

Baylor College of Medicine

Children's Hospital and Regional Medical Center

The Hospital for Sick Children

University of Heidelberg

University Children's Hospital

Longitudinal Study of Urea Cycle Disorders

hyperammonemia, developmental disabilities, long-term renal and hepatic effects, and case-fatality associated with the various forms of UCD

correlation between glutamine, ammonia, liver function (biomarkers) and severity scale and IQ in terms of outcome

Interim events related to treatments (drugs, diet or liver transplant)

ornithine/kräkning

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

Longitudinal Study of Urea Cycle Disorders

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