Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.

NCT01477320 | Completed Results DMC

• 1 other identifier: 11.0170
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Enteral Nutrition; Stress Ulcer Prophylaxis; Critically Ill Patients; Overt and significant GI bleeding; Stress gastropathy; Clostridium Difficile pseudomembranous colitis; Vital AF; Small peptide fish oil structured lipids; Fructose oligosaccharide

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With GI Bleeding

  1. 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. 2. 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 Outcomes (1)

• 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.

Study Arms (2)

Pantoprazole 40mg IV daily and tube feed

ACTIVE COMPARATOR

Drug: Pantoprazole 40 mg IV daily and tube feed.

Placebo and tube feed.

PLACEBO COMPARATOR

Other: Placebo and tube feed

Interventions

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.

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

Pantoprazole 40mg IV daily and tube feed

Placebo and tube feed OTHER

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

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

Placebo and tube feed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohamed Saad: lead
• Abbott Nutrition: collaborator
• University of Louisville: collaborator

Study Sites (1)

University of Louisville hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Enterocolitis, Pseudomembranous

Interventions

Pantoprazole; Enteral Nutrition

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Results Point of Contact

• Title: Dr. Mohamed Saad
• Organization: University of Louisville

mohamed.saad@louisville.edu

5028525841

Study Officials

• Mohamed Saad, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: November 22, 2011
• Study Start: September 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 16, 2018
• Results First Posted: January 16, 2018

Record last verified: 2017-12

Locations

US (1)