REducing Deaths due to OXidative Stress: the REDOXS© Study

ISRCTN ISRCTN48486094
DOI https://doi.org/10.1186/ISRCTN48486094
ClinicalTrials.gov (NCT) NCT00133978
Protocol serial number MCT-82214
Sponsor Queen's University (Canada)
Funders Canadian Institutes of Health Research (ref: MCT-82214), Fresenius-Kabi (Germany), Clinical Teachers Association of Queen’s University (Canada)
Submission date
27/12/2006
Registration date
27/12/2006
Last edited
22/03/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daren Keith Heyland
Scientific

Clinical Evaluation Research Unit
Angada 4
Kingston General Hospital
Kingston
K7L 2V7
Canada

+1 (0)613 549 6666 ext 3339
dkh2@queensu.ca
Dr Rupinder Dhaliwal
Public

Clinical Evaluation Research Unit (CERU)
Angada 4
Kingston General Hospital
Kingston
K7L 2V7
Canada

+1 (0)613 549 6666 ext 3830
dhaliwar@KGH.KARI.NET

Study information

Primary study designInterventional
Study designMulticentre non-pharmaceutical randomised factorial 2x2 design, placebo trial with study participants, investigator, caregiver, study nurses gathering data, outcome assessor, and data analyst blinded.
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleREducing Deaths due to OXidative Stress: a randomised trial of glutamine and anti-oxidant supplementation in critically ill patients
Study acronymREDOXS©
Study objectivesPrimary hypothesis:
Glutamine and antioxidant supplementation improves the survival of critically ill patients or reduces 28 day mortality.

Secondary hypothesis:
Glutamine and antioxidant supplementation will have a favourable effect on duration of mechanical ventilation, stay in Intensive Care Unit (ICU) and hospital, development of infectious complications, multiple organ dysfunction, antibiotic use, mitochondrial function and quality of life.
Ethics approval(s)Research Ethics Board of Queen's University Health Sciences and Affilated Teaching Hospitals (Canada), 22/03/2006
Health condition(s) or problem(s) studiedSevere organ dysfunction/critical illness
Intervention1. Glutamine: 0.35 g/kg/day glutamine parenterally and 30 g/day enterally for a maximum of 28 days
2. Antioxidants: 500 µg of selenium/day parenterally and selenium 300 µg, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg per day enterally for a maximum of 28 days
3. Glutamine and Antioxidants: Combination of glutamine and antioxidant treatments once daily for a maximum of 28 days
4. Placebo: normal saline parenterally and matching enteral placebo for a maximum of 28 days
Intervention typeSupplement
Primary outcome measure(s)

Mortality at 28th day

Key secondary outcome measure(s)

1. Duration of mechanical ventilation, end of ICU stay
2. Stay in ICU and hospital, end of ICU and hospital stay
3. Development of infectious complications, throughout ICU stay
4. Multiple organ dysfunction, throughout ICU stay
5. Antibiotic use, throughout ICU stay
6. Mitochondrial function, throughout ICU stay
7. 36-item Short Form health survey (SF-36), quality of life survey, at three months and six months from ICU admission

Completion date31/01/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration1200
Key inclusion criteria1. Mechanically ventilated adult patients (more than or equal to 18 years old, either sex) admitted to ICU
2. Two or more of the following organ failures related to their acute illness:
2.1. A Partial Pressure of Oxygen in Arterial Blood (PaO2)/Fraction of Inspired Oxygen (FiO2) ratio of less than or equal to 300
2.2. Clinical evidence of hypoperfusion defined as the need for vasopressor agents (norepinephrine, epinephrine, vasopressin, more than or equal to 5 µg/kg/min of dopamine, or more than or equal to 50 µg/min phenylephrine) for greater than or equal to two hours
2.3. In patients without known renal disease, renal dysfunction defined as a serum creatinine more than or equal to 171 µmol/L or a urine output of less than 500 ml/last 24 hours (or 80 ml/last four hours if a 24 hour period of observation not available). In patients with acute on chronic renal failure (pre-dialysis), an absolute increase of more than or equal to 80 µmol/L from baseline or pre-admission creatinine or a urine output of less than 500 ml/last 24 hours (or 80 ml/last four hours) will be required
2.4. A platelet count of less than 50 x 10^9/L
Key exclusion criteria1. More than 24 hours from admission to ICU
2. Patients who are moribund (not expected to be in ICU for more than 48 hours due to imminent death)
3. A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week)
4. Absolute contraindication to enteral nutrients (e.g., Gastro-Intestinal (GI) perforation, obstruction or no GI tract access for any reason)
5. Patients with severe acquired brain injury:
5.1. Significant head trauma (defined as an injury, in the opinion of the investigator, that represents a severe, disabling, or fatal brain injury)
5.2. Grade four or five subarachnoid haemorrhage
5.3. Stroke resulting in coma and intubation
5.4. Post-cardiac arrest with suspected significant anoxic brain injury
6. Seizure disorder requiring anticonvulsant medication
7. Cirrhosis - Child's class C liver disease
8. Metastatic cancer or Stage IV Lymphoma with life expectancy less than six months
9. Routine elective cardiac surgery (patients with complicated peri-operative course requiring pressors, Intra-Aortic Balloon Pump (IABP), ventricular assist devices can be included)
10. Patients with primary admission diagnosis of burns (more than or equal to 30% Body Surface Area [BSA])
11. Weight less than 50 kg or greater than 200 kg
12. Pregnant patients or lactating with the intent to breastfeed
13. Previous randomisation in this study
14. Enrolment in a related ICU interventional study
Date of first enrolment01/01/2007
Date of final enrolment31/01/2010

Locations

Countries of recruitment

  • Canada

Study participating centre

Kingston General Hospital
Kingston
K7L 2V7
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/04/2013 Yes No
Basic results No No
Other publications rationale and study design 01/08/2006 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

22/03/2016: added link to results - basic reporting.

BMC - Part of Springer Nature Springer Nature