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The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury

2014-08-27 03:19:03 | BioPortfolio

Summary

The purpose of this study is to test the following hypotheses:

1. Enteral glutamine administration decreases in-hospital mortality in adult subjects with severe thermal burn injuries.

2. Enteral glutamine administration decreases infectious morbidity and shortens length of care in adult subjects with severe thermal burn injuries.

3. Enteral glutamine administration decreases the cost of care of adult subjects with severe thermal burn injuries.

The objectives of this proposed pilot trial relate to evaluating the feasibility of the study protocol. Specifically, the investigators want to assess the following outcomes in a sample of 200 patients in 7 sites:

1. Number of patients enrolled per site per month and reasons for non-enrollment.

2. Rate of consent for eligible patients.

3. Rate of adherence to study interventions and reasons for non-adherence

Description

Enteral glutamine has been found to decrease mortality in critically ill patients and blood infection in trauma patients. In our pilot study (Critical Care Medicine, 2003, 31:2444) we found the same protective effect of glutamine against blood infection in severely burned adult patients. In addition, a significant decrease in mortality was observed with glutamine. These results should be tested with a multi-center trial because our study was small and did not have mortality as an end point. Since such a large multi center study has never been conducted in burn patients, a pilot study that will test its feasibility seems warranted.

The mechanism of action of glutamine is controversial. Improvement in T cell immune functions, anti-oxidant properties and a newly discovered action on heat shock proteins could all be involved. If our clinical hypothesis is supported by the results of this trial, additional grant proposals will be made to test several mechanistic hypotheses, using blood samples obtained from a randomly determined sub-group of patients stratified for severity of the injury.

The specific aims of the pilot study will be to determine recruitment rates, compliance with nutritional burn management protocol and with study intervention. Clinical outcomes will be: mortality, incidence of infectious episodes, clinical status during the ICU stay and length of care in adult with severe burns.

The study will be a multi-center, prospective, double blinded, and controlled randomised clinical trial. Randomization will be concealed and stratified for burn severity. Patients will be adults, between 18 and 80 years, admitted within 24h post burn, and with a Total Burn Surface Area (TBSA) + Age score between 60 and 120, TBSA being ≥ 20% and requiring grafting. The pilot study will include approximately 6 burn centers, 3 in Canada and 3 in the US and enrol 200 patients over three years. These patients will be included in the final analysis of the complete trial. Compliance with study protocols and with study intervention will be assessed through regular on site visits, regular phone contacts and teleconferences.

Glutamine or a placebo will be given every 6 hours at 0.5 gm/kg/day as boluses, until complete healing. Resuscitation, nutritional support, pain management, infection control and surgical care will be done according to standardized procedures.

Two 10 ml samples of blood will be obtained on day 4, 7, 14 and 21 to test the effect of glutamine on inflammatory response and the time-course of inflammation, immunosuppression and the production of heat shock proteins Samples will be drawn on CPT tubes for white blood cells isolation.

The end points of the study are: Primary: Recruitment rates, Compliance with study protocols and compliance with study intervention. Secondary: mortality, incidence of infectious episodes, ICU length of care, length of care, and multiple organ functions. The cost-effectiveness of glutamine administration will also be measured if the results show a decrease in length of care or a reduced incidence of infections with glutamine. These outcomes will be measured but not analysed during this pilot trial.

The Data will be collected and managed by a professional and centralized organization for multi centres clinical research (Clinical Evaluation Research Unit, Kingston, Ontario, Canada).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Burns

Intervention

Enteral Glutamine, Placebo

Location

Department of Burn Surgery Shriners Hospital for Children Northern California
Sacramento
California
United States
95817

Status

Not yet recruiting

Source

Clinical Evaluation Research Unit at Kingston General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:03-0400

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Medical and Biotech [MESH] Definitions

Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like.

Nutritional support given via the alimentary canal or any route connected to the gastrointestinal system (i.e., the enteral route). This includes oral feeding, sip feeding, and tube feeding using nasogastric, gastrostomy, and jejunostomy tubes.

Burns of the respiratory tract caused by heat or inhaled chemicals.

Burns caused by contact with or exposure to CAUSTICS or strong ACIDS.

Burns produced by contact with electric current or from a sudden discharge of electricity.

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