NCT00553423

Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients

Detailed description

Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. To date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. No study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients. We hypothesize that prophylactic use of Lactulose decreases the risk of development of hepatic encephalopathy with upper GI bleed in cirrhotics.

Conditions

• Hepatocerebral Encephalopathy
• Portal-Systemic Encephalopathy
• Encephalopathy, Hepatic
• Encephalopathy, Hepatocerebral

Interventions

Type	Name	Description
DRUG	Lactulose	Lactulose 30 ml q6h for 48 hrs
DRUG	Placebo	Placebo 30 ml q6hrly for 48 hrs

Timeline

• Start date: 2007-11-01
• Completion: 2008-11-01
• First posted: 2007-11-05
• Last updated: 2007-11-05

Locations

2 sites across 1 country: Pakistan