The purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.
Background: Critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. Supplementation with key nutrients, like glutamine and antioxidants, is most likely to have a favourable effect on these physiological parameters leading to an improvement in clinical outcomes. The results of two separate meta-analyses suggested that glutamine and antioxidants may be associated with improved survival. We have recently completed a dosing study to determine the maximal tolerable dose (MTD) of glutamine dipeptides and antioxidants in critically ill patients with evidence of hypoperfusion. The purpose of this protocol is to evaluate the effect of high dose glutamine and antioxidant supplementation on mortality in a large scale randomized trial. Study Intervention: Patients will be randomized to receive glutamine supplementation or antioxidant supplementation (or respective placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,223
0.35 gm/kg/day parenterally and 30 gms/day enterally
500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally
0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg
28-day Mortality
28-day mortality/status: at 28 days after randomization;
Time frame: Day 28
ICU Length of Stay
Measure of the duration of participant stay in the ICU
Time frame: Day 28
ICU Acquired Infection
We have made some modifications the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) to operationalize the adjudication of infections in this trial. We grade the certainty of the diagnosis of infection using definitions for 'Definite', 'Probable', and 'Possible' for each category of infection. The categories of infection are: Deep surgical wound infection, Incisional (or superficial) surgical wound infection, Skin and soft-tissue infection (non-surgical) (SSTS), Catheter-related blood stream infections (CRI), Primary blood stream infections (BSI), Lower urinary tract infection, Upper urinary tract infection, Intra abdominal infection, Sinusitis, Lower respiratory tract infection (excluding pneumonia), ICU Acquired Pneumonia and Other.
Time frame: Day 28
Hospital Length of Stay
Measure of the duration of the participant's hospital stay
Time frame: 6 months (from ICU admission)
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Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)
Univ. of Colorado at Denver and Health Sciences Center
Aurora, Colorado, United States
University of Louisville
Louisville, Kentucky, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Texas
Houston, Texas, United States
Fletcher Allan Centre
Burlington, Vermont, United States
UZ Brussels
Brussels, Belgium
University Hospital
Liège, Belgium
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Grey Nun's Hospital, Edmonton
Edmonton, Alberta, Canada
Vancouver Hospital
Vancouver, British Columbia, Canada
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