Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Overview[ - collapse ][ - ]

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.
ConditionGastrointestinal Hemorrhage
Clostridium Difficile Colitis
InterventionDrug: Pantoprazole 40 mg IV daily and tube feed.
Other: Placebo and tube feed
PhaseN/A
SponsorRodrigo Cavallazzi
Responsible PartyUniversity of Louisville
ClinicalTrials.gov IdentifierNCT01477320
First ReceivedOctober 4, 2011
Last UpdatedJuly 1, 2013
Last verifiedJuly 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 4, 2011
Last Updated DateJuly 1, 2013
Start DateAugust 2013
Estimated Primary Completion DateMarch 2015
Current Primary Outcome MeasuresGI 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]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.
Current Secondary Outcome Measures1. 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.

Descriptive Information[ + expand ][ + ]

Brief TitleEnteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
Official TitleEnteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
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 DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Condition
  • Gastrointestinal Hemorrhage
  • Clostridium Difficile Colitis
InterventionDrug: 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 1.2 Cal(TM),Abbott,Columbus,OH)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 1.2 Cal(TM),Abbott,Columbus,OH)
Study Arm (s)
  • Active Comparator: Pantoprazole 40mg IV daily and tube feed
  • Placebo Comparator: Placebo and tube feed.

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment198
Estimated Completion DateMarch 2015
Estimated Primary Completion DateAugust 2014
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Crissie DeSpirito, RN
502-852-0026
crissie.despirito@louisville.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01477320
Other Study ID Numbers11.0170
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of Louisville
Study SponsorRodrigo Cavallazzi
CollaboratorsAbbott Nutrition
University of Louisville
Investigators Principal Investigator: Rodrigo Cavallazzi, MD University of Louisville
Verification DateJuly 2013

Locations[ + expand ][ + ]

University of Louisville hospital
Louisville, Kentucky, United States, 40202
Contact: Crissie DeSpirito, RN | 502-852-0026 | crissie.despirito@louisville.edu
Principal Investigator: Rodrigo Cavallazzi, MD
Not yet recruiting