Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
- Registration Number
- NCT01175538
- Lead Sponsor
- Govind Ballabh Pant Hospital
- 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 development of first episode of hepatic encephalopathy is classified as primary prophylaxis of hepatic encephalopathy and preventing recurrence of hepatic encephalopathy in patients who had previous episode of hepatic encephalopathy is secondary prophylaxis of hepatic encephalopathy
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- cirrhotic patients(18-70yrs) who never had encephalopathy
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lactulose Lactulose -
- Primary Outcome Measures
Name Time Method prevention of first episode of hepatic encephalopathy 6 months
- Secondary Outcome Measures
Name Time Method Side effects to lactulose and mortality 6 months
Trial Locations
- Locations (1)
G B Pant Hospital
🇮🇳New Delhi, Delhi, India