The cardiovascular effects of hyperoxia during and shortly after CABG surgery

INTERVENTION: Trade Name: Conoxia Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion CONDITION: During and after coronary artery bypass graft operation we will investigate the cardiovascular effects of hyperoxia on blood pressure, cardiac function, microcirculation and ischemia/reperfusion. ; MedDRA version: 16.0 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease System Organ Class: 100000004866 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To study the effect of different target PaO2's on hemodynamics, microcirculation and ischemia/reperfusion injury in CABG patients.; Primary end point(s): ‐hemodynamic parameters (SVRI and C.I.) Secondary Objective: To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic patients and the normoxemic groups. ; Timepoint(s) of evaluation of this end point: During operation and ICU stay SECONDARY OUTCOME: Secondary end point(s): • microcirculation (SDF measurements) ; • ischemia/reperfusion injury ; • oxidative stress ; • tissue/organ perfusion ; • clinical endpoints (duration of mechanical ventilation, length of stay, mortality) ; Timepoint(s) of evaluation of this end point: • microcirculation (SDF measurements): at baseline, 30 min after start of operation, immediately after operation, and 3 hours after operation ; • ischemia/reperfusion injury:at baseline and 6 hours after CABG ; • oxidative stress: at baseline and 6 hours after CABG ; • tissue/organ perfusion: at baseline, immediately after operation, 6 and 12 hours after operation ; • clinical endpoints (duration of mechanical ventilation, length of stay, mortality): ongoing ; INCLUSION CRITERIA: ‐Age = 18 years ‐Non‐emergent CABG surgery 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30