N/A
N=124
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
Gastrointestinal Hemorrhage · Clostridium Difficile Colitis
Bottom Line
View on ClinicalTrials.gov: NCT01477320 ↗Enrolled (actual)
124
Serious AEs
1.6%
Results posted
Jan 2018
Primary outcome: Primary: Number of Subjects With GI Bleeding — 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pantoprazole 40 mg IV daily and tube feed. (Drug); Placebo and tube feed (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mohamed Saad
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With GI Bleeding |
1; 1 | — |
| SECONDARY Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. |
1; 3 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01477320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.