Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
Information source: Aga Khan University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocerebral Encephalopathy; Portal-Systemic Encephalopathy; Encephalopathy, Hepatic; Encephalopathy, Hepatocerebral
Intervention: Lactulose (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Aga Khan University Official(s) and/or principal investigator(s):
Shahid Majid, FCPS, Principal Investigator, Affiliation: Aga Khan University
Mohammad Salih, FCPS, Study Director, Affiliation: Aga Khan University
Shahid Ahmed, FCPS, Study Director, Affiliation: Aga Khan University
Wasim Jafri, FCPS, Study Chair, Affiliation: Aga Khan University
Overall contact:
Shahid Majid, FCPS, Phone: 9221-4930051, Ext: 4447, Email: shahid.majid@aku.edu
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
Clinical Details
Official title: Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Development of Clinically Overt Hepatic Encephalopathy
Secondary outcome: Death, hospital stay
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Shahid Majid, FCPS, Phone: 9221-4930051, Ext: 4447, Email: shahid.majid@aku.edu
Aga Khan university, Karachi, Sind 74800, Pakistan; Not yet recruiting
Shahid Majid, FCPS, Phone: 9221-4930051, Ext: 4447, Email: shahid.majid@aku.edu
Mohammad Salih, FCPS, Phone: 9221-4930051, Ext: 4528, Email: mohammad.salih@aku.edu
Shahid Majid, FCPS, Principal Investigator
Mohammad Salih, FCPS, Sub-Investigator
Shahid Ahmed, FCPS, Sub-Investigator
Wasim Jafri, FRCP, FACG, Sub-Investigator
Aga Khan University, Karachi, Sind 74800, Pakistan; Recruiting
Shahid Majid, FCPS, Phone: 9221-4930051, Ext: 4447, Email: shahid.majid@aku.edu
Mohammad Salih, FCPS, Phone: 9221-4930051, Ext: 4528, Email: mohammad.salih@aku.edu
Additional Information
Starting date: November 2007
Ending date: November 2008
Last updated: November 2, 2007
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