Project 170701

Effects of enteral glutamine supplementation on mortality and infectious morbidity in severely burned patients: a multi-center pilot trial

170701

Effects of enteral glutamine supplementation on mortality and infectious morbidity in severely burned patients: a multi-center pilot trial

$600,812
Project Information
Study Type: Trial Pilot_Feasibility_Study
Therapeutic Area: Critical_Care
Research Theme: Clinical
Disease Area: severe burns, sepsis
Data Type: Canadian
Institution & Funding
Principal Investigator(s): Garrel, Dominique R
Co-Investigator(s): Armour, Alexis D; Bernier, Jacques; Heyland, Daren K; Rinfret, Stéphane; Wischmeyer, Paul E
Institution: Université de Montréal
CIHR Institute: Nutrition, Metabolism and Diabetes
Program: Randomized Controlled Trials
Peer Review Committee: Randomized Controlled Trials - A (RSA)
Competition Year: 2008
Term: 2 yrs 0 mth
Abstract Summary

The aim of this study is to test the feasability of a multi center trial on the effects of glutamine on mortality and infectious morbidity in adult burn patient. This will include recruitment rate, compliance with institutionnal and protocol regulations, and compliance with study intervention and data collection. Glutamine has been shown to decrease infections in patients treated in intensive care settings or after surgery. In burn patient, 2 small studies have shown decreased blood infection with glutamine administration and in one study mortality was much lower in patients with glutamine than in patients with placebo. This unexpected finding prompted us to propose a multi center study with a large number of patients. Since a trial of this mmagnitude has never been conducted we propose to conduct a feasability study that will include a fraction of the patient population recruted by a fraction of the participating centers. All clinical outcome will be measured and the study patients will be included in the final analysis, should the complete study be conducted.

Research Characteristics

This project includes the following research characteristics:

Scalability Assessment
Barrier Identification
Multicenter
Knowledge Translation Focus
Safety Focus
Time to Event
Composite Endpoint
Vulnerable Populations
Study Justification

"test the feasability of a multi center trial on the effects of glutamine on mortality and infectious morbidity in adult burn patient"

Novelty Statement

"in one study mortality was much lower in patients with glutamine than in patients with placebo. This unexpected finding prompted us to propose a multi center study with a large number of patients."

Methodology Innovation

multi-center pilot feasibility trial of enteral glutamine in severely burned patients

Keywords
Enteral Glutamine Supplements Human Subjects Mortality Nutrition Sepsis Severe Burns