Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/01/2010
Date assigned
20/01/2010
Last edited
21/03/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Wischmeyer

ORCID ID

Contact details

University of Colorado Denver
Department of Anesthesiology
12700 East 19th Avenue
RC2
Room 7119
Aurora
80045
United States of America
+1 720 848 6745
paul.wischmeyer@ucdenver.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00985205

Protocol/serial number

CIHR #190808, MCT-94834; DOD# 09155001

Study information

Scientific title

Effects of enteral glutamine supplementation on mortality and infectious morbidity in severely burned patients: a multicentre randomised double blind controlled trial

Acronym

RE-ENERGIZE

Study hypothesis

This research proposal is based on 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

As of 21/03/2012, the following changes have been made to the record.
Anticipated start date has been modified from 01/06/2010 to 01/12/2010.
Anticipated end date has been modified from 01/06/2012 to 01/03/2013.

Ethics approval

Added on 21/03/2012:
Ethics approval expires on 7th February 2013.

Added 25/05/2010:
Colorado Multiple Institutional Review Board approved on the 7th April 2010 (ref: 10-0046). Expires 6th April 2011.

Study design

Multicentre randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe thermal burn injuries

Intervention

Patients will be randomly allocated to two groups:

Glutamine group:
Patients will receive glutamine (L-glutamine) powder mixed with water through their feeding tube, every 4 hours or three times a day if given orally, for a total of 0.5 g/kg/day. The glutamine powder will be supplied in pre-packaged aliquots of 5 grams and will be delivered to the ICU in blinded sachets and will be mixed in with water at the bedside by the patient's nurse.

Control group:
Patients will receive maltodextrin (placebo) mixed with water instead of glutamine.

Joint sponsor details:
Université de Montreal (Canada)
C.P. 6128, succursale Centre-ville
Montréal (Québec) H3C 3J7
Canada
http://www.umontreal.ca

University of Colorado (USA)
Department of Anesthesiology
12700 East 19th Avenue
Aurora 80045
United States of America
http://www.ucdenver.edu

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Death: Hospital mortality recorded until complete healing, defined as 7 days after the last grafting procedure.

Secondary outcome measures

1. Six-month mortality: mortality recorded during the 6 months following admission
2. Incidence of infections: according to the Centers for Disease Control and Prevention (CDC) or similar definitions for ventilation-related pneumonia, central line infection, positive blood culture, including germ identification, wound infection. Others: unusual infection such as abscesses, meningitis, peritonitis, etc.
3. Length of care (defined as length of healing): defined as 7 days after the last grafting operation
4. Length of mechanical ventilation: number of days on ventilator
5. Clinical status in the ICU: APACHE score at entry and SOFA score every day during the ICU stay until the discontinuation of mechanical ventilation. These scores are derived from the clinical and biological monitoring of the patients in the ICU and are standardised. All data needed for the calculation of these scores will be transferred to our electronic database and calculated automatically.
6. Length of time in the ICU. This will include all days with assisted ventilation. When a patient will be re-admitted to the ICU within 48 hrs for assisted ventilation after having been discharged, the total ventilation/day will be taken into account.

Overall trial start date

01/06/2010

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 21/03/2012
1. Total Burn Surface Area (TBSA):
TBSA ≥ 20% for patients ages 18 - 59 years OR
TBSA ≥ 10% for patients ages 60 - 80 years
2. Deep 2nd and/or 3rd degree burns requiring grafting
3. Age + TBSA = 40-119

Previous inclusion criteria
1. Age + total burn surface area (TBSA) = 60 - 120 (upper limit not included)
2. Deep 2nd and/or 3rd degree burns
3. TBSA greater than or equal to 20%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Current exclusion criteria as of 21/03/2012
1. > 72 hrs from admission to ICU to time of consent
2. Patients > 80 yrs or < 18 yrs of age
3. Liver cirrhosis - Child s class C liver disease
4. Pregnancy
5. Absolute contra-indication for EN (intestinal occlusion or perforation, abdominal injury)
6. Patients admitted > 48 hrs post burn (for patients that receive standardized burn care and resuscitation
prior to admission to ICU, this exclusion criteria may be extended to “Patients admitted > 96 hrs post
burn; if this is the case consent must be obtained within 24 hrs of admission to burn ICU according to
the judgement of the Site Investigator)
7. Patients with injuries from high voltage electrical shock
8. Patients who are moribund
9. Patients with BMI < 18 or > 50
10. Enrollment in another industry sponsored ICU intervention study (co-enrollment in academic studies will
be considered on a case by case basis)
11. Received glutamine supplement for > 24 hrs prior to randomization
12. Known allergy to maltodextrin, corn starch, corn, or corn products

Previous exclusion criteria
1. Greater than 48 hours from admission to intensive care unit (ICU) to time of consent
2. Patients older than 80 years or younger than 18 years of age (age of maturity for an eligible patient to obtain consent is 18 years in Canada and in the United States of America)
3. Liver cirrhosis: Child's class C liver disease
4. Pregnancy (urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice)
5. Associated multiple fractures or severe head trauma
6. Absolute contra-indication for enteral nutrition (EN): intestinal occlusion or perforation, abdominal injury
7. Patients admitted more than 48 hours post-burn (for patients that receive standardised burn care and resuscitation prior to admission to ICU, this exclusion criteria may be extended to "Patients admitted more than more than 72 hours post-burn" according to the judgement of the Site Investigator)
8. Patients with injuries from high voltage electrical shock
9. Patients who are moribund
10. Patients with extreme body sizes: body mass index (BMI) less than 18 or greater than 50 kg/m^2
11. Enrolment in another industry sponsored ICU intervention study (co-enrolment in academic studies will be considered on a case by case basis)

Recruitment start date

01/06/2010

Recruitment end date

01/06/2012

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

University of Colorado Denver
Aurora
80045
United States of America

Sponsor information

Organisation

Clinical Evaluation Research Unit (CERU) (Canada)

Sponsor details

Kingston General Hospital
76 Stuart Street
Kingston
Ontario
K7L 2V7
Canada
dominique.garrel@umontreal.ca

Sponsor type

Research organisation

Website

http://www.kgh.on.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 190808, MCT-94834)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

U.S. Department of Defense (USA) (ref: 09155001)

Alternative name(s)

United States Department of Defense, Department of Defense, DOD

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes