N/A
Completed N=124
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
Gastrointestinal Hemorrhage · Clostridium Difficile Colitis
Source: ClinicalTrials.gov NCT01477320 ↗
Enrolled (actual)
124
Serious AEs
1.6%
Results posted
Jan 2018
Primary outcomePrimary: Number of Subjects With GI Bleeding — 1; 1 participants
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.
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 | — |
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. Informational only — not medical advice.