Clinical Trial: Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose
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 Summary: 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
Sponsor: Govind Ballabh Pant Hospital
Current Primary Outcome: prevention of first episode of hepatic encephalopathy [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Side effects to lactulose and mortality [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Govind Ballabh Pant Hospital
Dates:
Date Received: August 2, 2010
Date Started: January 2008
Date Completion: September 2010
Last Updated: August 4, 2010
Last Verified: October 2009