Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastrointestinal Hemorrhage Clostridium Difficile Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pantoprazole 40mg IV daily and tube feed

Group Type ACTIVE_COMPARATOR

Pantoprazole 40 mg IV daily and tube feed.

Intervention Type DRUG

Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.

Placebo and tube feed.

Group Type PLACEBO_COMPARATOR

Placebo and tube feed

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Placebo and tube feed

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

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No