â??PREVENTION OF HEPATIC ENCEPHALOPATHY IN PATIENTS WITH LIVER CIRRHOSISâ??
Phase 3
Completed
- Conditions
- Health Condition 1: null- patients with cirrhosis with no previous overt hepatic encephalopathy
- Registration Number
- CTRI/2012/07/002807
- Lead Sponsor
- G B Pant Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Cirrhotic patients, age 18-75 years.
No history of overt hepatic encephalopathy
Exclusion Criteria
Patients on lactulose therapy
History of recent alcohol intake (in past 4 weeks)
Recent infection or antibiotic use (in past 6 weeks)
Patients on secondary prophylaxis for spontaneous bacterial peritonitis
Recent G I bleeding
Hepatocellular carcinoma
Previous TIPS and shunt surgeries
Use of psychotropic drugs which may affect psychometric tests
Any neurologic disease such as Alzheimerâ??s disease, Parkinsonâ??s disease and nonhepatic metabolic encephalopathies
Significant heart, respiratory or renal failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method development of overt hepatic encephalopathy in two groupsTimepoint: six months after recruitment of last patient in the study
- Secondary Outcome Measures
Name Time Method Baseline psychometric test, critical flicker frequency (CFF), SIBO, oro-cecal transit time and blood ammonia level as predictor of development of hepatic encephalopathy.Timepoint: 6 month after recruitment of last patient