Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Mohamed Saad

Status: Completed

Conditions: Gastrointestinal Hemorrhage; Clostridium Difficile Colitis

Treatments: Drug: Pantoprazole 40 mg IV daily and tube feed.; Other: Placebo and tube feed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01477320

11.0170

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups, including a placebo group

Pantoprazole 40mg IV daily and tube feed

Active Comparator group

Treatment:

Drug: Pantoprazole 40 mg IV daily and tube feed.

Placebo and tube feed.

Placebo Comparator group

Treatment:

Other: Placebo and tube feed