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

This study is currently recruiting participants.
Verified July 2017 by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985205
First Posted: September 28, 2009
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
  Purpose

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

  1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries.
  2. Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries.
  3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care.

The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 2,700 patients in 80 sites:

  1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality?
  2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?

Condition Intervention Phase
Burns Dietary Supplement: Enteral Glutamine Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Enteral Glutamine Supplementation on Mortality and Infectious Morbidity in Severely Burned Patients: a Multi-center Pilot Trial

Resource links provided by NLM:


Further study details as provided by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • 6 Month Mortality [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • Time to Discharge Alive [ Time Frame: 6 months ]

Other Outcome Measures:
  • Health-Related Quality of Life - in particular the physical function domain of the SF-36, ADL, and IADL questionnaires. [ Time Frame: 6 Month ]
  • Incidence of acquired bacteremia due to Gram negative organisms [ Time Frame: 3 Months ]
  • Hospital Mortality [ Time Frame: 3 Months ]
  • Duration of Mechanical Ventilation [ Time Frame: 3 months ]
  • ICU Stay [ Time Frame: 3 Months ]
  • Hospital Stay [ Time Frame: 3 Months ]

Estimated Enrollment: 2700
Study Start Date: December 2010
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enteral Glutamine
0.5 g/kg/day mixed in water and given via nasogastric tube as boluses q 4 hrs or TID if po
Dietary Supplement: Enteral Glutamine
0.5g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs or TID if po.
Other Name: Glutamine
Placebo Comparator: Placebo
Mixed in with water and given via nasogastric tube as boluses q 4hrs or TID if po
Dietary Supplement: Placebo
Maltodextrin mixed with water given via NG tube Q 4 hours or TID if po.
Other Name: Maltodextrin

Detailed Description:

Burn injuries represent a public health problem worldwide, ranked fourth in all injuries and are among the leading cause of disability adjusted life years in low and middle-income countries. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies, thereby predisposing patients to impaired immune function and increased risk of developing infectious complications, organ dysfunction, and death. Consequently, over the last few decades numerous trials have evaluated the impact of different nutrition/nutrient strategies in severe burns patients. Glutamine is of particular interest in this regard as it appears vital for a number of key stress-response pathways in serious illness. The existing randomized trials of glutamine supplementation in burns patients have suggested a significant reduction in mortality, infection, and hospital length of stay. However, in other critically ill patient populations, there is a signal of increased mortality associated with glutamine administration. Given this conflicting evidence, burn practitioners are either harming or saving lives with glutamine use. The purpose of the current proposal is to provide the rationale for a large, multicenter clinical trial of supplemental enteral glutamine in 2700 severe burn injury patients. We hypothesize that the inexpensive therapeutic strategy tested in this randomized controlled trial will lead to lower morbidity and mortality and reduced health care costs in an otherwise very devastating and disabling injury worldwide.

In our pilot study (Critical Care Medicine, 2003, 31:2444) we found a 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.

The specific aims of the study are to determine the overall treatment effect and safety of glutamine in burn patients. Clinical outcomes will be: mortality, time to discharge alive, incidence of acquired bacteremia due to Gram negative organisms, hospital mortality, duration of mechanical ventilation, ICU stay and hospital stay. 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.

The study will be a large, multicenter, double-blind, pragmatic, randomized controlled trial of 2,700 patients with severe burns randomly allocated to receive enteral glutamine or placebo. Randomization will be concealed and stratified by site allocating patinets 1:1 to either glutamine or matching placebo by the method of permuted blocks of random undisclosed size within strata. Patients will be adults, a minimum of 18 years old, with deep 2nd and/or 3rd degree burns requiring grafting, and for patients age 18 - 39 years a (Total Body Surface Area) TBSA burn ≥ 20% or in the presence of an inhalation injury a minimum of 15% TBSA burn is required; for patients age 40 - 59 years a TBSA burn > 15% is required; for patients aged 60 years or older a TBSA burn ≥ 10% is required. The study will include approximately 80 burn centers in Canada, the US, Europe and Latin America. Patients will receive glutamine or a placebo through their feeding tube, every 4 hours or TID if taking things by mouth, for a total of 0.5 g/kg/day for patients with a BMI <35. Patients with a BMI >35 will receive 0.5 g/kg/day based on an obesity-adjusted body weight. The study intervention will be administered until >7 days after the last successful grafting operation or until discharge from acute care unit or 3 months from admission, whichever comes first. Resuscitation, nutritional support, pain management, infection control and surgical care will be done according to standardized procedures.

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Deep 2nd and/or 3rd degree burns requiring grafting
  2. Patient meets one of the following 4 criteria:

    1. Patients 18 - 39 years of age with ≥ 20% TBSA* burn
    2. Patients 18 - 39 years of age with ≥ 15% TBSA* burn and with inhalation injury
    3. Patients 40 - 59 years of age with ≥ 15% TBSA* burn
    4. Patients ≥ 60 years of age ≥ 10% TBSA* *TBSA - Total Body Surface Area

Exclusion Criteria:

  1. > 72 hrs from admission to ICU to time of consent.
  2. Patients younger than 18 years of age.
  3. a) Patients without known renal disease and renal dysfunction defined as a serum creatinine >171 µmol/L or a urine output of less than 500 mL/last 24 hours (or 80 mL/last 4 hours if a 24 hour period of observation is not available).

    b) Patients with acute on chronic renal failure (pre-dialysis) with an absolute increase of >80 µmol/L from baseline or pre-admission creatinine or a urine output of <500 mL/last 24 hours (or 80 mL/last 4 hours).

    c) Patients with chronic renal failure on dialysis will be excluded.

  4. Liver cirrhosis - Child-Pugh class C liver disease
  5. Pregnant or lactating females.
  6. Contra-indication for EN: intestinal occlusion or perforation, intra-abdominal injury.
  7. Patients with injuries from high voltage electrical contact.
  8. Patients who are moribund (not expected to survive the next 72 hours).
  9. Patients with extreme body sizes: BMI < 18 or > 50
  10. Enrollment in another industry sponsored ICU intervention study.
  11. Received glutamine supplement for > 24 hrs prior to randomization
  12. Known allergy to maltodextrin, corn starch, corn, corn products or glutamine.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985205


Contacts
Contact: Maureen Dansereau 613 549 6666 ext 6686 danserem@kgh.kari.net
Contact: Daren Heyland, MD dkh2@queensu.ca

  Show 37 Study Locations
Sponsors and Collaborators
Daren K. Heyland
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Daren Heyland, MD Queen's University
  More Information

Additional Information:
Publications:
Responsible Party: Daren K. Heyland, Professor of Medicine, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT00985205     History of Changes
Other Study ID Numbers: RE-ENERGIZE
CIHR # 190808 ( Other Grant/Funding Number: CIHR )
First Submitted: September 25, 2009
First Posted: September 28, 2009
Last Update Posted: August 10, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital:
Randomized Clinical Trial
Glutamine
Themal Burn Injuries
Nutrition
Outcome Assessment
Critical Care
Total Body Surface Area