NCT01175538

Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: Govind Ballabh Pant Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Lactulose	In the Gp-L group, patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day
DRUG	Lactulose	lactulose will be used in 30-60ml/day

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-06-01
• Completion: 2010-09-01
• First posted: 2010-08-05
• Last updated: 2010-08-05

Locations

1 site across 1 country: India