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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00133978
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Critical Illness
Sepsis
Multiple Organ Failure
Interventions Other: Glutamine
Other: Antioxidants
Other: Glutamine + Antioxidants
Other: Placebo
Enrollment 1223
Recruitment Details 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 Written informed consent was obtained from patients or their legal representatives before enrollment.
Arm/Group Title Glutamine Antioxidants Glutamine + Antioxidants Placebo
Hide Arm/Group Description 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. 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 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.

Non-isonitrogenic, iso-caloric placebo solution
Period Title: Overall Study
Started 303 308 310 302
Completed 301 307 310 300
Not Completed 2 1 0 2
Arm/Group Title Glutamine Antioxidants Glutamine + Antioxidants Placebo Total
Hide Arm/Group Description Glutamine supplementation Antioxidant supplementation Glutamine and antioxidant supplementation Non-isonitrogenic, iso-caloric placebo solution Total of all reporting groups
Overall Number of Baseline Participants 301 307 310 300 1218
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 310 participants 300 participants 1218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
161
  53.5%
156
  50.8%
145
  46.8%
159
  53.0%
621
  51.0%
>=65 years
140
  46.5%
151
  49.2%
165
  53.2%
141
  47.0%
597
  49.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 307 participants 310 participants 300 participants 1218 participants
62.5  (15.0) 63.6  (14.3) 64.3  (14.0) 62.8  (13.7) 63.3  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 310 participants 300 participants 1218 participants
Female
110
  36.5%
130
  42.3%
130
  41.9%
122
  40.7%
492
  40.4%
Male
191
  63.5%
177
  57.7%
180
  58.1%
178
  59.3%
726
  59.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 310 participants 300 participants 1218 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
1.Primary Outcome
Title 28-day Mortality
Hide Description 28-day mortality/status: at 28 days after randomization;
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine Antioxidants Glutamine + Antioxidants Placebo
Hide Arm/Group Description:
Glutamine supplementation
Antioxidant supplementation
Glutamine and antioxidant supplementation
Non-isonitrogenic, iso-caloric placebo solution
Overall Number of Participants Analyzed 301 307 310 300
Measure Type: Number
Unit of Measure: participants
97 89 101 76
2.Secondary Outcome
Title ICU Length of Stay
Hide Description Measure of the duration of participant stay in the ICU
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine Antioxidants Glutamine + Antioxidants Placebo
Hide Arm/Group Description:
Glutamine supplementation
Antioxidant supplementation
Glutamine and antioxidant supplementation
Non-isonitrogenic, iso-caloric placebo solution
Overall Number of Participants Analyzed 301 307 310 300
Median (Inter-Quartile Range)
Unit of Measure: days
8.9
(5.6 to 16.0)
8.9
(4.8 to 15.6)
8.9
(5.0 to 15.1)
8.3
(4.3 to 16.9)
3.Secondary Outcome
Title ICU Acquired Infection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine No Glutamine Antioxidants No Antioxidants
Hide Arm/Group Description:
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.
Non-isonitrogenic, iso-caloric placebo solution
500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
Non-isonitrogenic, iso-caloric placebo solution
Overall Number of Participants Analyzed 611 607 617 601
Measure Type: Number
Unit of Measure: participants
All Infections 183 166 168 181
Infections classified as 'definite' or 'probable' 118 120 110 128
Microbiological Confirmed 92 87 83 96
4.Secondary Outcome
Title Hospital Length of Stay
Hide Description Measure of the duration of the participant's hospital stay
Time Frame 6 months (from ICU admission)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine Antioxidants Glutamine + Antioxidants Placebo
Hide Arm/Group Description:
Glutamine supplementation
Antioxidant supplementation
Glutamine and antioxidant supplementation
Non-isonitrogenic, iso-caloric placebo solution
Overall Number of Participants Analyzed 301 307 310 300
Median (Inter-Quartile Range)
Unit of Measure: days
17.1
(9.0 to 35.1)
16.0
(8.0 to 31.4)
16.9
(8.2 to 37.0)
16.5
(7.2 to 36.2)
Time Frame April 2005 and December 2011
Adverse Event Reporting Description We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
 
Arm/Group Title Glutamine Antioxidants Glutamine + Antioxidants Placebo
Hide Arm/Group Description 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. Antioxidant supplementation 500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.

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 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.

Non-isonitrogenic, iso-caloric placebo solution
All-Cause Mortality
Glutamine Antioxidants Glutamine + Antioxidants Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Glutamine Antioxidants Glutamine + Antioxidants Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/301 (4.65%)      11/307 (3.58%)      11/310 (3.55%)      10/300 (3.33%)    
Cardiac disorders         
Cardiac Disorders   7/301 (2.33%)  7 2/307 (0.65%)  2 5/310 (1.61%)  5 5/300 (1.67%)  5
Eye disorders         
Eye Disorders   0/301 (0.00%)  0 1/307 (0.33%)  1 0/310 (0.00%)  0 0/300 (0.00%)  0
Gastrointestinal disorders         
GI Disease   2/301 (0.66%)  2 5/307 (1.63%)  5 3/310 (0.97%)  3 5/300 (1.67%)  5
Hepatobiliary disorders         
Hepatobiliary Disorders   0/301 (0.00%)  0 0/301 (0.00%)  0 1/310 (0.32%)  1 0/300 (0.00%)  0
Nervous system disorders         
Nervous System Disorders   4/301 (1.33%)  4 3/307 (0.98%)  3 2/310 (0.65%)  2 2/300 (0.67%)  2
Respiratory, thoracic and mediastinal disorders         
Respiratory Disorders   0/301 (0.00%)  0 1/307 (0.33%)  1 0/310 (0.00%)  0 0/300 (0.00%)  0
Surgical and medical procedures         
Procedural Complications   1/301 (0.33%)  1 0/307 (0.00%)  0 0/310 (0.00%)  0 2/300 (0.67%)  2
Vascular disorders         
Vascular Disorders   0/301 (0.00%)  0 0/307 (0.00%)  0 1/310 (0.32%)  1 0/300 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glutamine Antioxidants Glutamine + Antioxidants Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/301 (0.00%)      0/307 (0.00%)      0/310 (0.00%)      0/300 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Dr. Daren Heyland
Organization: Clinical Evaluation Research Unit
Phone: 613-549-6666 ext 4847
EMail: dkh2@queensu.ca
Layout table for additonal information
Responsible Party: Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT00133978    
Other Study ID Numbers: REDOXS
EudraCT-No: 2007-001831-73
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: April 29, 2013
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014