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
Conditions
Interventions
Trade Name: Conoxia
Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: -Pregnancy -Non-elective surgery -Combined cardiac surgery (heart valve combined with CABG surgery) - Off-pump-CABG -Presence of pre/perioperative intra-aortic balloon pump -Medical history positive for COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of different target PaO2's on hemodynamics, microcirculation and ischemia/reperfusion injury in CABG patients. ;Secondary Objective: To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic patients and the normoxemic groups. ;Primary end point(s): -hemodynamic parameters (SVRI and C.I.);Timepoint(s) of evaluation of this end point: During operation and ICU stay | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Intensive care
VU University Medical Center
Outcome results
None listed