REducing Deaths due to OXidative Stress The REDOXS© Study A 2×2 factorial randomized trial of glutamine and antioxidant supplementation in critically ill patients - REDOXS©

• Conditions: Critically ill patients

• Registration Number: EUCTR2007-001831-73-DE
• Lead Sponsor: Kingston General Hospital, Queen's University of Kingston

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-13
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Patients must meet ALL inclusion criterias:

1. Signed informed consent has been obtained from the patient or his/her legally acceptable representative
2. Mechanically ventilated adult patients (>18 years old) admitted to ICU will be considered eligible if they have 2 or more of the following organ failures related to their acute illness:

- A PaO2/FiO2 ratio of <300;

- Clinical evidence of hypoperfusion defined as the need for vasopressor agents (norepinephrine, epinephrine, vasopressin, > 5 µg/kg/min of dopamine, or > 50 µg/min phenylephrine) for greater than or equal to 2 hours;

- In patients without known renal disease, renal dysfunction defined as a serum creatinine >171 µmol/L or a urine out-put of less than 500 ml/last 24 hours (or 80 ml/last 4 hours if a 24 hour period of observation not available). In pa-tients with acute on chronic renal failure (pre-dialysis), an absolute increase of > 80 µmol/L from baseline or pre-admission creatinine or a urine output of < 500 ml/last 24 hours (or 80 ml/last 4 hours) will be required;

- A platelet count of < 50 x109/l.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded for any of the following reasons:

1. > 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., GI perforation, obstruction or no GI tract access for any reason)
5. Patients with severe acquired brain injury
a)Significant head trauma (defined as an injury in the opinion of the investigator,
that represents a severe, disabling, or fatal brain injury)
b)Grade 4 or 5 subarachnoid haemorrhage
c) Stroke resulting in coma and intubation
d) Post-cardiac arrest with suspected significant an-oxic 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 expec-tancy < 6 months
9. Routine elective cardiac surgery (patients with complicated peri-operative course requiring pressors, IABP, ventricular assist devices can be included)
10. Patients with primary admission diagnosis of burns (> 30% body surface area
11. Known or suspected hypersensitivity to component(s) of study medication
12. Hereditary metabolic disorder in regards to component(s) of study medication
13. Weight less than 50 kg or greater than 200 kg
14. Pregnant patients or lactating with the intent to breastfeed. Females of child-bearing potential should have a negative urine or serum pregnancy test within 24 h prior to administration of study medication
15. Previous randomization in this study
16. Enrollment in a related ICU interventional study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified