None listed
Conditions
Interventions
Intervention1: L-ornithine hydrochloride plus sodium phenylacetate): 0.15 g/kg/day, 0.3 g/kg/day, or 0.6 g/kg/day or placebo as a 4-hour intravenous infusion in divided doses every 12 hours for 5 days
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men and women ≥18 and ≤ 70 years; 2.Acute liver failure, defined as the development of coagulopathy and encephalopathy in a subject without preexisting liver disease and illness of ≤ 4 weeks; 3.Ammonia level > 100 mol/L (normal ≤50 mol/L); 4.Written informed consent from the subject and/or authorized legal representative.
Exclusion criteria
Exclusion criteria: 1.History of cirrhosis; or liver disease of > 4 weeks duration; 2.Cerebral oedema, or need for either mechanical ventilation or endotracheal intubation; 3.Current evidence of alcoholic hepatitis, biliary obstruction, malarial hepatopathy, or ischemic hepatitis; 4.Anasarca or intractable ascites; 5.Active bleeding; 6.Haemodynamic instability, defined by a mean arterial pressure of <60mmHg or the requirement for inotropes; 7.Cardiopulmonary complications (such as pulmonary oedema, aspiration pneumonia, heart failure); 8.Creatinine &#8805; 1.5 mg/dL; 9.Pregnancy by serum pregnancy test or ultrasound ; 10.Hepatic or extrahepatic malignancy within the past five years 11.Focal neurologic signs; 12.Non-hepatic causes of altered mental status; 13.Recent (<1 week) administration of any sedative drug; 14. Treatment with L-ornithine L-aspartate (LOLA), lactulose, or other ammonia lowering therapies; 15.Concomitant drug administration that is known to interfere with metabolism of either ornithine, phenylacetate or both, such as antibiotics of the penicillin group and valproic acid; 16. Prior history of HIV with an AIDS-defining event; 17. Other major physical or major psychiatric illness that in the opinion of the investigator would affect the subject?s ability to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of arterial ammonia compared to Baseline in UCL-L1V versus placebo-treated subjects.Timepoint: Change in arterial ammonia level from day 0 (Baseline) to day 5 (End of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects progressing to cerebral oedema, defined as the presence of spontaneous or inducible decerebrate posturing or by the presence of any two of the following: hypertension (blood pressure, &#8805;150/90 mm Hg), bradycardia, pupillary changes, or neurogenic hyperventilation; 2. Change in survival and survival time (defined as the time interval from admission to death among non-survivors); 3. Change in West Haven Scale; 4. Change in Glasgow Coma Score; 5. Proportion of subjects requiring mechanical ventilation or endotracheal intubation.Timepoint: These parameters will be assessed on daily from day 0 (Baseline) to day 12 whether these complications are becoming less frequent or not | — |
Countries
India
Contacts
Public ContactDR SUBRAT KUMAR ACHARYA
Outcome results
None listed