Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Mohamed Saad124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

124

Conditions

Gastrointestinal Hemorrhage Clostridium Difficile Colitis

Interventions

Pantoprazole 40 mg IV daily and tube feed.DRUG

Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.

Placebo and tube feedOTHER

Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Louisville hospital

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Number of Subjects With GI Bleeding

1. 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. 2. 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.

Time frame: 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 Outcomes

Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.

Time frame: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.

Data from ClinicalTrials.gov

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