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Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

This study is not yet open for participant recruitment.
Verified January 2013 by University of Louisville
Sponsor:
Collaborators:
Abbott Nutrition
University of Louisville
Information provided by (Responsible Party):
Mohamed Saad, University of Louisville
ClinicalTrials.gov Identifier:
NCT01477320
First received: October 4, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Gastrointestinal Hemorrhage
Clostridium Difficile Colitis
 Drug: Pantoprazole 40 mg IV daily and tube feed.
Other: Placebo and tube feed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • GI bleeding [ Time Frame: Time to event :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 ] [ Designated as safety issue: Yes ]
    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. Cost to the pharmacy for care related to stress ulcer prophylaxis and treatment of GI bleeding. 2.Incidence of ICU-acquired C. Difficile pseudomembranous colitis. [ Time Frame: Time to event: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds. ] [ Designated as safety issue: Yes ]
    Cost to the pharmacy for care related to stress ulcer prophylaxis and treatment of GI bleeding (overt or significant) for patients receiving a PPI agent plus EN versus patients placed on EN alone.


Estimated Enrollment: 198
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 1.2 Cal(TM),Abbott,Columbus,OH)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477320

Contacts
Contact: Crissie DeSpirito, RN 502-852-0026 crissie.despirito@louisville.edu
Contact: Karim El-Kersh, MD 502-852-5841 kaelke01@louisville.edu

Locations
United States, Kentucky
University of Louisville hospital Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Crissie DeSpirito, RN     502-852-0026     crissie.despirito@louisville.edu    
Principal Investigator: Mohamed Saad, MD, FCCP            
Sponsors and Collaborators
Mohamed Saad
Abbott Nutrition
University of Louisville
Investigators
Principal Investigator: Mohamed Saad, MD, FCCP University of Louisville
  More Information

No publications provided

Responsible Party: Mohamed Saad, Primary Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT01477320     History of Changes
Other Study ID Numbers: 11.0170
Study First Received: October 4, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Colitis
Critical Illness
Gastrointestinal Hemorrhage
Hemorrhage
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Disease Attributes
Pathologic Processes
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013