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Feasibility of the REDOXS study – reducing deaths due to oxidative stress: a randomized pilot trial of glutamine and antioxidant supplementation in critically ill patients
Critical Care volume 11, Article number: P154 (2007)
A large randomized trial is needed to evaluate the safety and efficacy of glutamine (GLN) and antioxidant (AOX) supplements. However, high doses of such nutrients via enteral and parenteral routes early in the course of critical illness is often interrupted by high illness acuity and other treatment priorities. The purpose of this pilot trial was to evaluate the feasibility of delivering high-dose GLN and AOX supplements early on in the course of critical illness, and to estimate recruitment for the larger REDOXS study.
In six Canadian centers, using a 2 × 2 factorial design, we randomized mechanically ventilated adults who had two or more organ failures within 24 hours of ICU admission to one of four groups: (1) GLN (0.35 g/kg/day i.v. plus 30 g enterally), (2) AOX (500 μg selenium i.v. and 300 μg selenium, 20 mg zinc, 10 mg β-carotene, 500 mg vitamin E, and 1,500 mg vitamin C enterally), (3) both AOX + GLN, and (4) placebo. Supplementation was continued for a minimum of 5 days up to 28 days and was provided independent of nutrition support. We recorded the time from ICU admission to randomization, the time to start of supplements and nutrition support parameters.
From April 2005 to April 2006, 80 patients were randomized (average 2.1/site/month). The median time from ICU admission to randomization was 18.2 hours (range 11.6–21.1 hours). All patients received parenteral supplements, the median (range) time to start was 2.7 hours (2.0–3.8 hours) and 78/80 (98%) received enteral supplements with a median (range) of 2.6 hours (1.9–4.5 hours) from randomization. The mean duration of supplements was 11.1 days (enteral) and 12.2 days (parenteral). The mean volumes of enteral and parenteral supplements received were 84% (range 45–102%) and 93% (range 54–100%) prescribed volumes, respectively. The average prescribed energy and protein intakes were 1,802 kcal/day and 86 g protein/day but the average daily percentage energy and protein received from nutrition support was only 65% (range 4–95%) and 62% (range 2–97%) of that prescribed, respectively.
In critically ill patients with organ failure we provided adequate amounts of study supplements via both enteral and parenteral routes in the early phases of acute illness, independent of nutrition support. We estimated recruitment of at least two patients/site/month for our future trial.
This study was supported by grants from the Canadian Institutes of Health Research and Fresenius-Kabi, Germany.
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Heyland, D., Dhaliwal, R., Muscedere, J. et al. Feasibility of the REDOXS study – reducing deaths due to oxidative stress: a randomized pilot trial of glutamine and antioxidant supplementation in critically ill patients. Crit Care 11, P154 (2007). https://doi.org/10.1186/cc5314
- Critical Illness
- Nutrition Support
- Pilot Trial
- Parenteral Route
- Parenteral Supplement