Role of L-Ornithine L-Aspartate in improving acute encephalopathy (altered sensorium) in patients with Liver Cirrhosis
- Conditions
- Health Condition 1: null- Hepatic cirrhosis
- Registration Number
- CTRI/2013/02/003360
- Lead Sponsor
- Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 164
a. Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data.
b. Patients with overt acute grade 2, 3 and 4 HE, according to the West Haven criteria.
c. Age of patient >18 years
d. Patients with or without a precipitating factor for the HE.
a.Patients who are terminally ill (End Stage Liver Disease, MELD more than 15)
b.Chronic HE, on Lactulose or antibiotics
c.Acute superposed liver injury (hepatitis) or acute on chronic liver failure
d.Severe septicemia with shock
e.Hepatocellular carcinoma
f. Wilsonâ??s disease as the etiological factor of liver disease
g. Advanced cardiac or pulmonary disease
h.Acute renal failure or end stage renal disease
i.Neuro-degenerative disease or major psychiatric illness
j.Patients on sedatives or antidepressants
k.Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mental state gradeTimepoint: 5 days
- Secondary Outcome Measures
Name Time Method Blood ammonia levels <br/ ><br> <br/ ><br>Timepoint: 5 days;Hospital stayTimepoint: 4 weeks;MortalityTimepoint: 4 weeks