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REducing Deaths due to OXidative Stress: the REDOXS© Study
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| ISRCTN | ISRCTN48486094 |
| ClinicalTrials.gov identifier | NCT00133978 |
| Public title |
REducing Deaths due to OXidative Stress: the REDOXS© Study
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| Scientific title | REducing Deaths due to OXidative Stress: a randomised trial of glutamine and anti-oxidant supplementation in critically ill patients |
| Acronym | REDOXS© |
| Serial number at source | MCT-82214 |
| Study hypothesis |
Primary 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. |
| Lay summary | |
| Ethics approval | Approval received from the Research Ethics Board of Queen's University Health Sciences and Affilated Teaching Hospitals (Canada) on the 22 March, 2006. |
| Study design | Multicentre non-pharmaceutical randomised factorial 2x2 design, placebo trial with study participants, investigator, caregiver, study nurses gathering data, outcome assessor, and data analyst blinded. |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Severe organ dysfunction/critical illness |
| Participants - inclusion criteria |
1. 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 |
| Participants - exclusion criteria |
1. 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 |
| Anticipated start date | 01/01/2007 |
| Anticipated end date | 31/01/2010 |
| Status of trial | Completed |
| Patient information material | Can be found at http://www.criticalcarenutrition.com/index.php?option=com_content&task=view&id=19&Itemid=42 |
| Target number of participants | 1200 |
| Interventions |
1. 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 Contact for public queries: Rupinder Dhaliwal, RD Project Leader Clinical Evaluation Research Unit (CERU) Angada 4 Kingston General Hospital Phone: +1 613 549 6666 ext 3830 Cell: +1 613 484 3830 Fax: +1 613 548 2428 Email: dhaliwar@KGH.KARI.NET |
| Primary outcome measure(s) | Mortality at 28th day. |
| 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 |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82214)
2. Fresenius-Kabi (Germany) 3. Clinical Teachers Association of Queen’s University (Canada) |
| Trial website | http://www.criticalcarenutrition.com/redoxs |
| Publications | 2006 rationale and study design in http://www.ncbi.nlm.nih.gov/pubmed/16923310 |
| Contact name | Dr Daren Keith Heyland |
| Address |
Clinical Evaluation Research Unit
Angada 4 Kingston General Hospital Kingston |
| City/town | Ontario |
| Zip/Postcode | K7L 2V7 |
| Country | Canada |
| Tel | +1 613 549 6666 ext 3339 |
| Fax | +1 613 548 2428 |
| dkh2@queensu.ca | |
| Sponsor | Queen's University (Canada) |
| Address |
Rideau Building
Kingston |
| City/town | Ontario |
| Zip/Postcode | K7L 3N6 |
| Country | Canada |
| Tel | +1 613 533 2050 |
| Fax | +1 613 533 6433 |
| gerrondg@post.queensu.ca | |
| Sponsor website: | http://www.queensu.ca/ |
| Date applied | 27/12/2006 |
| Last edited | 13/07/2009 |
| Date ISRCTN assigned | 27/12/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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