ew amonia lowering treatment in patients with Acute Liver Failure which may improve survival frequency in them

Phase 2

Not yet recruiting

• Registration Number: CTRI/2009/091/000772
• Lead Sponsor: AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 18

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified