Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

This study has been completed.
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 26, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Mohamed Saad, 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 ]
    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. ]
    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.


Enrollment: 124
Study Start Date: September 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 26, 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

ClinicalTrials.gov processed this record on May 25, 2017