Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT00985205
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00985205
Study Brief:
Protocol Section:
NCT00985205