Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled Trial

Study Overview
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Brief Summary
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Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.

Detailed Description
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Mucosal erosions can occur on luminal surface of stomach in approximately 75-100% patients during the first 24 hours of intensive care unit admission. These erosions often cause bleeding with penetrating superficial capillaries. Clinically significant bleeding (Significant decrease in blood pressure or decrease in hemoglobin level of more than 2 g / dL) appears to be less than 5% in ICU patients. Enteral nutrition (EN) has protective effects against stress ulcer bleeding by neutralizing the acidic pH in the stomach lumen, providing a structural and functional integrity of the mucosal surface and trophic effect on the GI mucosa. These effects have been shown in some studies. The above-mentioned studies are inadequate for clinicians to make suggestions for relation between enteral nutrition and stress ulcer hemorrhage. The risk factors for stress ulcer hemorrhage are mechanical ventilation, coagulopathy and burns. Proton pump inhibitors (PPI) and histamine receptor blockers (H2RB) are the main drugs used for stress ulcer bleeding prophylaxis. Studies have shown that 90% of patients admitted to intensive care units receive prophylaxis for stress ulcer bleeding. Drugs (H2RB, PPI) used for prophylaxis against stress ulcer bleeding have some undesirable harmful effects in critical illnesses. These drugs, which suppress gastric acid secretion, can cause hospital-associated pneumonia and Clostridium difficile enterocolitis. The studies, for clinical proposals are generally performed in the 1980s and early 1990s. Oral intake was stopped in most of the critically ill patients and early enteral nutrition was not widely used at the time of these major studies performed. Patients who are receiving EN have been shown to develop less stress ulcer bleeding in some studies. In a limited number of animal studies, enteral feeding has been shown to protect stress-related mucosal damage in the gastric mucosa.

Official Title
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Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled

Conditions
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Enteral Nutrition, Gastro Intestinal Bleeding, Stress Ulcer Prophylaxis, Proton Pump Inhibitor

Intervention / Treatment
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* Drug: enteral nutrition + proton pump inhibitor
* Other: enteral nutrition only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Admission to ICU Expected to stay in ICU >24 hours No contraindications to EN within the first 24 hours after admission to the intensive care unit Exclusion Criteria: Evidence of active GI bleeding during current hospitalization prior to study entry Coagulopathy (PLT<50.000, INR>1.5, aPTT>2xcontrol) Patients receiving acid suppressing drugs prior to admission Pregnancy or lactation History/documented gastric ulcer Burn>30% body surface area Head injury or increased intracranial pressure Partial or complete gastrectomy Shock Multi-system trauma Exposure to gastric irritant drugs Patients not giving informed consent

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enteral nutrion only<br> | Other: enteral nutrition only<br>* Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive only enteral nutrition.<br>|
| Other: Enteral nutrion + proton pump inhibitor<br> | Drug: enteral nutrition + proton pump inhibitor<br>* Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive enteral nutrition and proton pump inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI bleeding | Overt GI bleeding (presence of coffee ground emesis hematemesis, melena or hematochezia. Significant GI bleeding, defined by 3-point decrease in hematocrit within 24 hours accompanied by 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 up to four weeks |