Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients (REDOXS)
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ClinicalTrials.gov Identifier: NCT00133978 |
Recruitment Status
:
Completed
First Posted
: August 24, 2005
Results First Posted
: September 9, 2014
Last Update Posted
: September 9, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | August 22, 2005 | |||
First Posted Date ICMJE | August 24, 2005 | |||
Results First Submitted Date | April 29, 2013 | |||
Results First Posted Date | September 9, 2014 | |||
Last Update Posted Date | September 9, 2014 | |||
Study Start Date ICMJE | April 2005 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
28-day Mortality [ Time Frame: Day 28 ] 28-day mortality/status: at 28 days after randomization;
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Original Primary Outcome Measures ICMJE |
The primary outcome for this study is 28-day mortality. | |||
Change History | Complete list of historical versions of study NCT00133978 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
The secondary outcomes are duration of stay in ICU, adjudicated diagnosis of infection, multiple organ dysfunction, duration of mechanical ventilation, hospital length of stay, and health-related quality of life at 3 and 6 months. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients | |||
Official Title ICMJE | REducing Deaths Due to OXidative Stress The REDOXS© Study | |||
Brief 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). |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1223 | |||
Original Enrollment ICMJE |
1200 | |||
Actual Study Completion Date | May 2012 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, Germany, Switzerland, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00133978 | |||
Other Study ID Numbers ICMJE | REDOXS EudraCT-No: 2007-001831-73 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital | |||
Study Sponsor ICMJE | Daren K. Heyland | |||
Collaborators ICMJE | Fresenius Kabi | |||
Investigators ICMJE |
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PRS Account | Clinical Evaluation Research Unit at Kingston General Hospital | |||
Verification Date | August 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |