NCT02321072.

Trial name or title	The effects of hyperoxia on organ dysfunction and outcome in critically ill patients with SIRS (O2‐ICU)
Methods	RCT
Participants	Patients admitted to the ICU with ≥ 2 positive SIRS criteria and an expected ICU stay of more than 48 hours
Interventions	Active comparator: high‐normal PaO2 In participants requiring respiratory monitoring, supplemental oxygen is titrated to achieve a PaO2 of 120 mmHg (16 kPa), range 105 to 135 mmHg (14 to 18 kPa). Active comparator: low‐normal PaO2 In participants requiring respiratory monitoring, supplemental oxygen is titrated to achieve a target PaO2 of 75 mmHg (10 kPa), range 60 to 90 mmHg (8 to 18 kPa).
Outcomes	Primary outcome Daily delta SOFA score (time frame: 14 days) Secondary outcomes: Total maximum SOFA score minus SOFA score on admission (time frame: 14 days) SOFA rate of decline (time frame: 14 days) Total maximum SOFA score, total maximum SOFA score minus SOFA score on admission, SOFA rate of decline (time frame: 14 days) Mortality (time frame: 14 days, in‐ICU (max 90 days), in‐hospital (max 90 days) Hypoxic events (PaO2 < 55 mmHg) (time frame: 14 days) Vasopressor or inotrope requirements (time frame: 14 days) Renal function, fluid balance (time frame: 14 days) Oxidative stress (F2‐isoprostanes) (time frame: days 1, 3, 7) Duration of mechanical ventilation and ventilator‐free days (time frame: 14 days) Length of stay (ICU) (time frame: average expected 2 to 28 days) Length of stay (hospital) (time frame: average expected 10 to 28 days) Systemic vascular resistance index (time frame: 14 days) in a random subpopulation Cardiac index (time frame: 14 days) in a random subpopulation Microcirculatory flow index and perfused vessel density (time frame: 14 days) in a random subpopulation. Composite endpoint for 2 sidestream dark‐field microcirculatory measurements
Starting date	February 2015
Contact information	Dr HJS de Grooth
Notes