Status:
UNKNOWN
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
Lead Sponsor:
Govind Ballabh Pant Hospital
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.
Detailed Description
Development of hepatic encephalopathy in a patient with cirrhosis is associated with poor survival rate of 10-70% at one year depending upon hepatic and renal functions. Treating patients to prevent d...
Eligibility Criteria
Inclusion
- cirrhotic patients(18-70yrs) who never had encephalopathy
Exclusion
- history of taking lactulose in the past 6 weeks
- alcohol intake during the past 6 weeks
- hepatocellular carcinoma
- previous TIPS or shunt surgery
- significant co morbid illness such as heart, respiratory, or renal failure
- neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
- patients on psychoactive drugs such as antidepressants or sedatives
- who restarted alcohol during follow up
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01175538
Start Date
January 1 2008
End Date
September 1 2010
Last Update
August 5 2010
Active Locations (1)
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1
G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India, 110002