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11 February 2012
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| [ Print-friendly version ] |
| The RE-ENERGIZE study: a RandomisEd trial of ENtERal Glutamine to minimIZE thermal injury |
| ISRCTN | ISRCTN92905442 |
| ClinicalTrials.gov identifier | NCT00985205 |
| Public title | The RE-ENERGIZE study: a RandomisEd trial of ENtERal Glutamine to minimIZE thermal injury |
| 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 |
| Serial number at source | CIHR #190808, MCT-94834; DOD# 09155001 |
| 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 |
| Lay summary | |
| Ethics approval |
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 |
| Countries of recruitment | Canada, United States of America |
| Disease/condition/study domain | Severe thermal burn injuries |
| Participants - 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% |
| Participants - 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) |
| Anticipated start date | 01/06/2010 |
| Anticipated end date | 01/06/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 200 |
| Interventions |
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 |
| Primary outcome measure(s) | Death: Hospital mortality recorded until complete healing, defined as 7 days after the last grafting procedure. |
| Secondary outcome measure(s) |
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. |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 190808, MCT-94834)
2. U.S. Department of Defense (USA) (ref: 09155001) |
| Trial website | |
| Publications | |
| Contact name | Dr Paul Wischmeyer |
| Address |
University of Colorado Denver
Department of Anesthesiology 12700 East 19th Avenue RC2, Room 7119 |
| City/town | Aurora |
| Zip/Postcode | 80045 |
| Country | United States of America |
| Tel | +1 720 848 6745 |
| paul.wischmeyer@ucdenver.edu | |
| Sponsor | Clinical Evaluation Research Unit (CERU) (Canada) |
| Address |
Kingston General Hospital
76 Stuart Street |
| City/town | Kingston, Ontario |
| Zip/Postcode | K7L 2V7 |
| Country | Canada |
| dominique.garrel@umontreal.ca | |
| Sponsor website: | http://www.kgh.on.ca/ |
| Date applied | 13/01/2010 |
| Last edited | 25/05/2010 |
| Date ISRCTN assigned | 20/01/2010 |
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