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Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients (REDOXS)

This study has been completed.
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier:
NCT00133978
First received: August 22, 2005
Last updated: August 26, 2014
Last verified: August 2014
Results First Received: April 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Critical Illness
Sepsis
Multiple Organ Failure
Interventions: Other: Glutamine
Other: Antioxidants
Other: Glutamine + Antioxidants
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted between April 2005 and December 2011 in 40 ICUs in participating countries after local jurisdictional and institutional Research Ethics Board approval.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Written informed consent was obtained from patients or their legal representatives before enrollment.

Reporting Groups
  Description
Glutamine Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
Antioxidants Antioxidant supplementation 500 ug of selenium intravenously, and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
Glutamine + Antioxidants

Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.

500 ug of selenium intravenously , and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.

Placebo Non-isonitrogenic, iso-caloric placebo solution

Participant Flow:   Overall Study
    Glutamine   Antioxidants   Glutamine + Antioxidants   Placebo
STARTED   303   308   310   302 
COMPLETED   301   307   310   300 
NOT COMPLETED   2   1   0   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Five randomized patients were not evaluable because we could not ascertain their 28-day vital status leaving 1218 patients in the final intention-to-treat analysis.

Reporting Groups
  Description
Glutamine Glutamine supplementation
Antioxidants Antioxidant supplementation
Glutamine + Antioxidants Glutamine and antioxidant supplementation
Placebo Non-isonitrogenic, iso-caloric placebo solution
Total Total of all reporting groups

Baseline Measures
   Glutamine   Antioxidants   Glutamine + Antioxidants   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 301   307   310   300   1218 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   161   156   145   159   621 
>=65 years   140   151   165   141   597 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (15.0)   63.6  (14.3)   64.3  (14.0)   62.8  (13.7)   63.3  (14.3) 
Gender 
[Units: Participants]
         
Female   110   130   130   122   492 
Male   191   177   180   178   726 
Region of Enrollment 
[Units: Participants]
         
Canada   259   262   263   260   1044 
United States   32   34   34   31   131 
Germany   6   6   5   4   21 
Belgium   1   2   5   2   10 
Switzerland   3   3   3   3   12 


  Outcome Measures
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1.  Primary:   28-day Mortality   [ Time Frame: Day 28 ]

2.  Secondary:   ICU Length of Stay   [ Time Frame: Day 28 ]

3.  Secondary:   ICU Acquired Infection   [ Time Frame: Day 28 ]

4.  Secondary:   Hospital Length of Stay   [ Time Frame: 6 months (from ICU admission) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daren Heyland
Organization: Clinical Evaluation Research Unit
phone: 613-549-6666 ext 4847
e-mail: dkh2@queensu.ca


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT00133978     History of Changes
Other Study ID Numbers: REDOXS
EudraCT-No: 2007-001831-73
Study First Received: August 22, 2005
Results First Received: April 29, 2013
Last Updated: August 26, 2014
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research
Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices