REducing Deaths due to OXidative Stress: the REDOXS© Study

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1200

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/

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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