The RE-ENERGIZE study: a RandomisEd trial of ENtERal Glutamine to minimIZE thermal injury

ISRCTN	ISRCTN92905442
DOI	https://doi.org/10.1186/ISRCTN92905442
ClinicalTrials.gov number	NCT00985205
Secondary identifying numbers	CIHR #190808, MCT-94834; DOD# 09155001

Submission date: 13/01/2010
Registration date: 20/01/2010
Last edited: 13/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Wischmeyer
Scientific

University of Colorado Denver
Department of Anesthesiology
12700 East 19th Avenue
RC2, Room 7119
Aurora
80045
United States of America

Phone	+1 (0)720 848 6745
Email	paul.wischmeyer@ucdenver.edu

Study information

Study design	Multicentre randomised double-blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Effects of enteral glutamine supplementation on mortality and infectious morbidity in severely burned patients: a multicentre randomised double blind controlled trial
Study acronym	RE-ENERGIZE
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2010
Completion date	01/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Key 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%
Key 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)
Date of first enrolment	01/06/2010
Date of final enrolment	01/06/2012

Locations

Countries of recruitment

Canada
United States of America

Study participating centre

University of Colorado Denver

Aurora
80045
United States of America

Sponsor information

Clinical Evaluation Research Unit (CERU) (Canada)
Research organisation

Kingston General Hospital
76 Stuart Street
Kingston, Ontario
K7L 2V7
Canada

Email	dominique.garrel@umontreal.ca
Website	http://www.kgh.on.ca/
"ROR"	https://ror.org/02nkfan21

Funders

Funder type

Research organisation

Canadian Institutes of Health Research - http://www.cihr-irsc.gc.ca (ref: 190808, MCT-94834)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

U.S. Department of Defense (ref: 09155001)
Government organisation / National government

Alternative name(s): United States Department of Defense, Department of Defense, U.S. Dept of Defense, US Department of Defense, DOD, USDOD
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	12/12/2017	13/03/2019	Yes	No

Editorial Notes

13/03/2019: Publication reference added.