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Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Primary Purpose

Gastrointestinal Hemorrhage, Clostridium Difficile Colitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pantoprazole 40 mg IV daily and tube feed.
Placebo and tube feed
Sponsored by
Mohamed Saad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Hemorrhage focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pantoprazole 40mg IV daily and tube feed

Placebo and tube feed.

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2011
Last Updated
December 14, 2017
Sponsor
Mohamed Saad
Collaborators
Abbott Nutrition, University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT01477320
Brief Title
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
Official Title
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Saad
Collaborators
Abbott Nutrition, University of Louisville

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage, Clostridium Difficile Colitis
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pantoprazole 40mg IV daily and tube feed
Arm Type
Active Comparator
Arm Title
Placebo and tube feed.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pantoprazole 40 mg IV daily and tube feed.
Other Intervention Name(s)
Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)
Intervention Description
Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.
Intervention Type
Other
Intervention Name(s)
Placebo and tube feed
Other Intervention Name(s)
Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)
Intervention Description
Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.
Primary Outcome Measure Information:
Title
Number of Subjects With GI Bleeding
Description
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.
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Saad, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

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Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

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