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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Encephalopathy, Hepatic, Encephalopathy, Hepatocerebral

Intervention / Treatment
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* Drug: Lactulose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactulose 30 ml q6h for 48 hrs | Drug: Lactulose<br>* Lactulose 30 ml q6h for 48 hrs<br>|
| Placebo Comparator: 2<br>Placebo 30 ml q6 hrly for 48hrs | Drug: Placebo<br>* Placebo 30 ml q6hrly for 48 hrs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Clinically Overt Hepatic Encephalopathy |  | 48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, hospital stay |  | 48hrs |