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Sponsored by: |
Aga Khan University |
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Information provided by: | Aga Khan University |
ClinicalTrials.gov Identifier: | NCT00553423 |
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
Condition | Intervention | Phase |
---|---|---|
Hepatocerebral Encephalopathy Portal-Systemic Encephalopathy Encephalopathy, Hepatic Encephalopathy, Hepatocerebral |
Drug: Lactulose Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage |
Estimated Enrollment: | 128 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lactulose 30 ml q6h for 48 hrs
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Drug: Lactulose
Lactulose 30 ml q6h for 48 hrs
|
2: Placebo Comparator
Placebo 30 ml q6 hrly for 48hrs
|
Drug: Placebo
Placebo 30 ml q6hrly for 48 hrs
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shahid Majid, FCPS | 9221-4930051 ext 4447 | shahid.majid@aku.edu |
Contact: Mohammad Salih, FCPS | 9221-4930051 ext 4528 | mohammad.salih@aku.edu |
Pakistan, Sind | |
Aga Khan university | Not yet recruiting |
Karachi, Sind, Pakistan, 74800 | |
Contact: Shahid Majid, FCPS 9221-4930051 ext 4447 shahid.majid@aku.edu | |
Contact: Mohammad Salih, FCPS 9221-4930051 ext 4528 mohammad.salih@aku.edu | |
Principal Investigator: Shahid Majid, FCPS | |
Sub-Investigator: Mohammad Salih, FCPS | |
Sub-Investigator: Shahid Ahmed, FCPS | |
Sub-Investigator: Wasim Jafri, FRCP, FACG | |
Aga Khan University | Recruiting |
Karachi, Sind, Pakistan, 74800 | |
Contact: Shahid Majid, FCPS 9221-4930051 ext 4447 shahid.majid@aku.edu | |
Contact: Mohammad Salih, FCPS 9221-4930051 ext 4528 mohammad.salih@aku.edu |
Principal Investigator: | Shahid Majid, FCPS | Aga Khan University |
Study Director: | Mohammad Salih, FCPS | Aga Khan University |
Study Director: | Shahid Ahmed, FCPS | Aga Khan University |
Study Chair: | Wasim Jafri, FCPS | Aga Khan University |
Study ID Numbers: | 06GS013MED |
Study First Received: | November 2, 2007 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00553423 History of Changes |
Health Authority: | Pakistan: Research Ethics Committee |
Liver Diseases Neurotoxicity Syndromes Gastrointestinal Diseases Brain Damage, Chronic Disorders of Environmental Origin Hemorrhage Brain Diseases Signs and Symptoms Mental Disorders Brain Injuries Dementia Metabolic Disorder Neurobehavioral Manifestations Lactulose Hepatic Insufficiency |
Delirium Liver Failure Metabolic Diseases Poisoning Gastrointestinal Hemorrhage Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations |
Liver Diseases Neurotoxicity Syndromes Gastrointestinal Diseases Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Hemorrhage Brain Diseases Signs and Symptoms Pathologic Processes Mental Disorders Therapeutic Uses Neurobehavioral Manifestations Lactulose Hepatic Insufficiency |
Delirium Liver Failure Metabolic Diseases Nervous System Diseases Gastrointestinal Agents Poisoning Gastrointestinal Hemorrhage Central Nervous System Diseases Confusion Pharmacologic Actions Encephalitis Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |