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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lactulose 30 ml q6h for 48 hrs |
|
| 2 | Placebo Comparator | Placebo 30 ml q6 hrly for 48hrs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | Lactulose 30 ml q6h for 48 hrs |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Clinically Overt Hepatic Encephalopathy | 48hours |
| Measure | Description | Time Frame |
|---|---|---|
| Death, hospital stay | 48hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahid Majid, FCPS | Contact | 9221-4930051 | 4447 | shahid.majid@aku.edu |
| Mohammad Salih, FCPS | Contact | 9221-4930051 | 4528 | mohammad.salih@aku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shahid Majid, FCPS | Aga Khan University | Principal Investigator |
| Mohammad Salih, FCPS | Aga Khan University | Study Director |
| Shahid Ahmed, FCPS |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan university | Not yet recruiting | Karachi | Sindh | 74800 | Pakistan |
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| Drug |
Placebo 30 ml q6hrly for 48 hrs |
|
| Aga Khan University |
| Study Director |
| Wasim Jafri, FCPS | Aga Khan University | Study Chair |
| Aga Khan University | Recruiting | Karachi | Sindh | 74800 | Pakistan |
|
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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