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

Encephalopathy, Hepatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553423
• Other study ID #: 06GS013MED
• Status: Recruiting
• Phase: Phase 3
• First received: November 2, 2007
• Last updated: November 2, 2007
• Start date: November 2007
• Est. completion date: November 2008

Study information

• Verified date: October 2007
• Source: Aga Khan University
• Contact: Shahid Majid, FCPS
• Phone: 9221-4930051
• Email: shahid.majid[@]aku.edu
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

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

Exclusion Criteria:

• Increased a-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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Diseases
• Encephalopathy, Hepatic
• Encephalopathy, Hepatocerebral
• Gastrointestinal Hemorrhage
• Hepatic Encephalopathy
• Hepatocerebral Encephalopathy
• Portal-Systemic Encephalopathy

Intervention

Drug:
• Lactulose
Lactulose 30 ml q6h for 48 hrs
• Placebo
Placebo 30 ml q6hrly for 48 hrs

Locations

Country	Name	City	State
Pakistan	Aga Khan university	Karachi	Sind
Pakistan	Aga Khan University	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Clinically Overt Hepatic Encephalopathy		48hours
Secondary	Death, hospital stay		48hrs