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Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

NCT01477320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-01-16

Study results available
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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.

Conditions

  • Gastrointestinal Hemorrhage
  • Clostridium Difficile Colitis

Interventions

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

Placebo and tube feed

Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.

Sponsors & Collaborators

  • Abbott Nutrition

    collaborator INDUSTRY

  • University of Louisville

    collaborator OTHER

  • Mohamed Saad

    lead OTHER

Principal Investigators

  • Mohamed Saad, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477320 on ClinicalTrials.gov