Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.

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 Overview

• Status: Completed
• Conditions: Clostridium Difficile Colitis; Gastrointestinal Hemorrhage
• Intervention / Treatment: Drug: Pantoprazole 40 mg IV daily and tube feed.; Other: Placebo and tube feed

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pantoprazole 40mg IV daily and tube feed	Drug: Pantoprazole 40 mg IV daily and tube feed.; Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.; Other Names: Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)
Placebo Comparator: Placebo and tube feed.	Other: Placebo and tube feed; Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.; Other Names: Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With GI Bleeding	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.; 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.	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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Mohamed Saad
• Collaborators: Abbott Nutrition; University of Louisville
• Investigators: Principal Investigator: Mohamed Saad, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Enteral Nutrition; Stress Ulcer Prophylaxis; Critically Ill Patients; Overt and significant GI bleeding; Stress gastropathy; Clostridium Difficile pseudomembranous colitis; Vital AF; Small peptide fish oil structured lipids; Fructose oligosaccharide
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Hemorrhage; Critical Illness; Colitis; Gastrointestinal Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: 11.0170