Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Study Overview
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Brief Summary
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study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.

Official Title
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Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.

Conditions
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Gastrointestinal Hemorrhage, Clostridium Difficile Colitis

Intervention / Treatment
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* Drug: Pantoprazole 40 mg IV daily and tube feed.
* Other: Placebo and tube feed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital Expected need for mechanical ventilation > 48 hours No contraindication to EN within the first 24 hours after admission to the ICU Exclusion Criteria: Evidence of active GI bleeding during current hospitalization prior to study entry Admission to ICU with primary diagnosis of burn injury Closed head injury or increased intracranial pressure Partial or complete gastrectomy Pregnancy or lactation

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pantoprazole 40mg IV daily and tube feed<br> | Drug: Pantoprazole 40 mg IV daily and tube feed.<br>* Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily.<br>* Other names: Tube feed formula:(Vital AF Advanced Formula 1.2 Cal(TM),Abbott,Columbus,OH);|
| Placebo Comparator: Placebo and tube feed.<br> | Other: Placebo and tube feed<br>* Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo.<br>* Other names: Tube feed formula:(Vital AF Advanced Formula 1.2 Cal(TM),Abbott,Columbus,OH);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With GI Bleeding | Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period. | Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. |  | Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral Nutrition, Stress Ulcer Prophylaxis, Critically Ill Patients, Overt and significant GI bleeding, Stress gastropathy, Clostridium Difficile pseudomembranous colitis, Vital AF, Small peptide fish oil structured lipids, Fructose oligosaccharide