NCT00133978

Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients

REducing Deaths Due to OXidative Stress The REDOXS© Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,223 (actual)
• Sponsor: Daren K. Heyland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Critical Illness
• Sepsis
• Multiple Organ Failure

Interventions

Type	Name	Description
OTHER	Glutamine	0.35 gm/kg/day parenterally and 30 gms/day enterally
OTHER	Antioxidants	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
OTHER	Glutamine + Antioxidants	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
OTHER	Placebo	Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)

Timeline

• Start date: 2005-04-01
• Primary completion: 2011-12-01
• Completion: 2012-05-01
• First posted: 2005-08-24
• Last updated: 2021-01-07
• Results posted: 2014-09-09

Locations

34 sites across 5 countries: United States, Belgium, Canada, Germany, Switzerland