Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Not Applicable

Completed

• Conditions: Clostridium Difficile Colitis; Gastrointestinal Hemorrhage
• Interventions: Drug: Pantoprazole 40 mg IV daily and tube feed.; Other: Placebo and tube feed

• Registration Number: NCT01477320
• Lead Sponsor: Mohamed Saad

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Study Start: 2013-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-08-17
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Results First Posted: 2018-01-16
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pantoprazole 40mg IV daily and tube feed	Pantoprazole 40 mg IV daily and tube feed.	-
Placebo and tube feed.	Placebo and tube feed	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With GI Bleeding	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Louisville hospital; 🇺🇸 Louisville, Kentucky, United States