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

Phase 3

• Conditions: Hepatocerebral Encephalopathy; Portal-Systemic Encephalopathy; Encephalopathy, Hepatic; Encephalopathy, Hepatocerebral
• Interventions: Drug: Placebo; Drug: Lactulose

• Registration Number: NCT00553423
• Lead Sponsor: Aga Khan University

Brief 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.

Study Timeline

• Status Verified: 2007-10
• Study Start: 2007-11
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Last Update Submitted: 2007-11-02
• Study First Posted: 2007-11-04
• Last Update Posted: 2007-11-04
• Study Completion: 2008-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Age >18 years
• All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER

Exclusion Criteria

• Increased α-fetoprotein level/ Documented hepatoma
• Portal or hepatic vein thrombosis
• Large-volume or tense ascites requiring repeated therapeutic paracentesis
• Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis)
• Pregnancy
• Not willing to give consent to participate in the study
• Patients who are unable to read and write
• ER arrival time > 12 hrs from index bleed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo 30 ml q6 hrly for 48hrs
1	Lactulose	Lactulose 30 ml q6h for 48 hrs

Primary Outcome Measures

Name	Time	Method
Development of Clinically Overt Hepatic Encephalopathy	48hours

Secondary Outcome Measures

Name	Time	Method
Death, hospital stay	48hrs

Trial Locations

Locations (2)

Aga Khan university; 🇵🇰 Karachi, Sind, Pakistan

Aga Khan University; 🇵🇰 Karachi, Sind, Pakistan