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Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

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ClinicalTrials.gov Identifier: NCT01477320
Recruitment Status : Completed
First Posted : November 22, 2011
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Abbott Nutrition
University of Louisville
Information provided by (Responsible Party):
Mohamed Saad, University of Louisville

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Clostridium Difficile Colitis Drug: Pantoprazole 40 mg IV daily and tube feed. Other: Placebo and tube feed Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
Study Start Date : September 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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Arms and Interventions
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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 Name: 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 Name: Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With GI Bleeding [ 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. ]
    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 :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477320


Locations
United States, Kentucky
University of Louisville hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Mohamed Saad
Abbott Nutrition
University of Louisville
Investigators
Principal Investigator: Mohamed Saad, MD University of Louisville
More Information
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Responsible Party: Mohamed Saad, Primary Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT01477320     History of Changes
Other Study ID Numbers: 11.0170
First Posted: November 22, 2011    Key Record Dates
Results First Posted: January 16, 2018
Last Update Posted: January 16, 2018
Last Verified: December 2017

Keywords provided by Mohamed Saad, University of Louisville:
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:
Hemorrhage
Colitis
Critical Illness
Gastrointestinal Hemorrhage
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Disease Attributes
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action