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Completed

NCT Number: NCT01477320

Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

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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Key information

Conditions

Gastrointestinal Hemorrhage Bacterial Infections Bacterial Infections and Mycoses Clostridium Difficile Colitis Clostridium Infections Digestive System Diseases Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Hemorrhage Infections Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pantoprazole 40 mg IV daily and tube feed.

Drug

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 "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)

Placebo and tube feed

Other

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

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

Primary outcomes

  1. Number of Subjects With GI Bleeding

    Time frame: 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 up to 100 weeks.

    • 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.

Secondary outcomes

  1. Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.

    Time frame: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.

Sponsors and collaborators

Lead sponsor

Mohamed Saad

Other

Collaborators

  • Abbott Nutrition
  • University of Louisville

Registry information

Official study title

Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 22, 2011
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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