Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

Gastrointestinal Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477320
• Other study ID #: 11.0170
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: December 14, 2017
• Start date: September 2013
• Est. completion date: July 2016

Study information

• Verified date: December 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Colitis
• Colitis
• Critical Illness
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville hospital	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Mohamed Saad	Abbott Nutrition, University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With GI Bleeding	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.	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.
Secondary	Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.		Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.