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RE-ENERGIZE

Trial

Clinical Trial Title

Effects of Enteral Glutamine Supplementation on Mortality and Infectious Morbidity in Severely Burned Patients

Trial Status

Open to Enrollment

Start Date

September 14, 2010

Trial Type

Burn

Specific Condition

Severe Burns

Description

This study plans to learn more about the role of glutamine in protecting people from infection when they are critically ill. Burn patients tend to be at high risk for infection. Several studies in subjects who require intensive care suggest that giving glutamine has certain clinical benefits.

Patients will be allocated to 2 groups: Glutamine group: patients will receive glutamine and the Control group: patients will receive an iso-calorically delivered amount of maltodextrin (control) mixed with water through their feeding tube.

Eligibility Criteria

Inclusion Criteria:

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

  2. Patient meets one of the following 4 criteria:
  • Patients 18 - 39 years of age with ≥ 20% TBSA* burn
  • Patients 18 - 39 years of age with ≥ 15% TBSA* burn and with inhalation injury
  • Patients 40 - 59 years of age with ≥ 15% TBSA* burn
  • 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.

IRB Number

10675

Principal Investigator Name

Niknam Eshraghi, MD

Contact Name

Kristin Hickey

Phone

(503) 413-5447

Contact E-Mail

khickey@lhs.org

Last Updated: Wednesday, January 27, 2021 12:08:12 PM