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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

Tracking Information
First Submitted Date  ICMJE August 22, 2005
First Posted Date  ICMJE August 24, 2005
Results First Submitted Date  ICMJE April 29, 2013
Results First Posted Date  ICMJE 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
 (submitted: August 26, 2014)
28-day Mortality [ Time Frame: Day 28 ]
28-day mortality/status: at 28 days after randomization;
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
The primary outcome for this study is 28-day mortality.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
  • ICU Length of Stay [ Time Frame: Day 28 ]
    Measure of the duration of participant stay in the ICU
  • 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.
  • Hospital Length of Stay [ Time Frame: 6 months (from ICU admission) ]
    Measure of the duration of the participant's hospital stay
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Illness
  • Sepsis
  • Multiple Organ Failure
Intervention  ICMJE
  • 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 Name: Dipeptiven, Microselenium/Selenium injection/selenase, EN REDOX formula (from Fresenius Kabi, Germany)
  • Other: Placebo
    Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)
Study Arms  ICMJE
  • Experimental: Glutamine
    Glutamine supplementation
    Intervention: Other: Glutamine
  • Experimental: Antioxidants
    Antioxidant supplementation
    Intervention: Other: Antioxidants
  • Experimental: Glutamine + Antioxidants
    Glutamine and antioxidant supplementation
    Intervention: Other: Glutamine + Antioxidants
  • Placebo Comparator: Placebo
    Non-isonitrogenic, iso-caloric placebo solution
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2012)
1223
Original Enrollment  ICMJE
 (submitted: August 22, 2005)
1200
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
Study Chair: Daren Heyland, MD Clinical Evaluation Research Unit, Kingston General Hospital
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