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

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Data is not saved in preview.
"This study plans to learn more about the role of the nutritional supplement glutamine in burn patients."
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
burn, burn injury
Type:
Dietary Supplement study, Phase 3
Investigator:
Description
This study plans to learn more about the role of nutrition supplement glutamine (hereafter referred to as the study “Natural Health Product (NHP)”) in treating patients with severe burn injury. Burn patients are at high risk for developing infections, having prolonged hospital stays and have increased risk of death and disability. Several studies suggest that giving the study NHP to patients with severe burns has certain clinical benefits. The study NHP is a substance normally made in the body and can be found in your diet. This substance is important to the immune system during illness and stress. During severe illnesses, the body may not make enough glutamine to satisfy the body’s needs.
In this study, we hope to determine whether the study NHP decreases mortality, shortens the hospital length of stay, and improves the quality of life of burn patients.
This study requires
Supplementation of NHP or placebo either through diet or feeding tube while in ICU/burn unit
Questionnaires completed after discharge
Who can participate?
Inclusion Criteria:

1. Deep 2nd and/or 3rd degree burns requiring grafting

2. a.) Patients 18 - 59 years of age without inhalation injury TBSA* ≥ 20% b.) Patients 18 - 59 years of age with inhalation injury TBSA* ≥ 15% c.) Patients ≥ 60 years of age (with or without inhalation injury) TBSA* ≥ 10%

- TBSA - Total Burn Surface Area


Exclusion Criteria:

1. > 72 hrs from admission to ICU to time of consent.

2. Patients younger than 18 years of age

3. In patients without known renal disease, 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). In patients with acute on chronic renal failure (pre-dialysis), 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) will be required. Patients with chronic renal failure on dialysis will be excluded.

4. Liver cirrhosis - Child's class C liver disease

5. Pregnancy

6. Absolute contra-indication for EN: intestinal occlusion or perforation, abdominal injury

7. Patients with injuries from high voltage electrical shock

8. Patients who are moribund

9. Patients with extreme body sizes: BMI 50

10. Enrolment 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
Resources
Schedule
Study duration and period
During the length of stay in ICU for treatment of burn injury Follow up approximately 6 months
Recruitment period
From June 24, 2016
Location
UC Davis Health Burn Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Lynda Painting
Research Topic
Conditions:
  • Burns

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview