Working… Menu

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. Identifier: NCT00133978
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : September 9, 2014
Last Update Posted : January 7, 2021
Fresenius Kabi
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

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.

Condition or disease Intervention/treatment Phase
Critical Illness Sepsis Multiple Organ Failure Other: Glutamine Other: Antioxidants Other: Glutamine + Antioxidants Other: Placebo Not Applicable

Detailed Description:


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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1223 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: REducing Deaths Due to OXidative Stress The REDOXS© Study
Study Start Date : April 2005
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: Glutamine
Glutamine supplementation
Other: Glutamine
0.35 gm/kg/day parenterally and 30 gms/day enterally

Experimental: Antioxidants
Antioxidant supplementation
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

Experimental: Glutamine + Antioxidants
Glutamine and antioxidant supplementation
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 Name: Dipeptiven, Microselenium/Selenium injection/selenase, EN REDOX formula (from Fresenius Kabi, Germany)

Placebo Comparator: Placebo
Non-isonitrogenic, iso-caloric placebo solution
Other: Placebo
Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)

Primary Outcome Measures :
  1. 28-day Mortality [ Time Frame: Day 28 ]
    28-day mortality/status: at 28 days after randomization;

Secondary Outcome Measures :
  1. ICU Length of Stay [ Time Frame: Day 28 ]
    Measure of the duration of participant stay in the ICU

  2. ICU Acquired Infection [ Time Frame: Day 28 ]
    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.

  3. Hospital Length of Stay [ Time Frame: 6 months (from ICU admission) ]
    Measure of the duration of the participant's hospital stay

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mechanically ventilated patients > or = 18 years old
  • 2 or more organ failures related to acute illness

Exclusion Criteria:

  • > 24 hours from admission to ICU
  • Patients who are moribund
  • Lack of commitment to aggressive care
  • Absolute contraindication to enteral nutrients
  • Severe acquired brain injury
  • Routine elective cardiac surgery
  • Primary admission of burns > 30% body surface area
  • Weight < 50 kgms or > 200 kgms
  • Pregnant or lactating patients
  • Previous randomization in this study
  • Enrollment in a related ICU interventional study
  • Child's class C liver disease
  • Metastatic cancer with life expectancy < 6 months
  • Seizure disorder requiring anticonvulsant medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133978

Show Show 34 study locations
Sponsors and Collaborators
Daren K. Heyland
Fresenius Kabi
Layout table for investigator information
Study Chair: Daren Heyland, MD Clinical Evaluation Research Unit, Kingston General Hospital
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daren K. Heyland, Director, Clinical Evaluation Research Unit at Kingston General Hospital Identifier: NCT00133978    
Other Study ID Numbers: REDOXS
EudraCT-No: 2007-001831-73
First Posted: August 24, 2005    Key Record Dates
Results First Posted: September 9, 2014
Last Update Posted: January 7, 2021
Last Verified: December 2020
Keywords provided by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital:
randomized trial
organ failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Multiple Organ Failure
Disease Attributes
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances