E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
We will study the effect of different amounts of oxygen during and immediately after cardiac surgery on blood pressure, the function of the heart and the small blood vessels |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051615 |
E.1.2 | Term | Atherosclerotic cardiovascular disease |
E.1.2 | System Organ Class | 100000004866 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the effect of different target PaO2's on hemodynamics, microcirculation and ischemia/reperfusion injury in CABG patients.
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E.2.2 | Secondary objectives of the trial |
To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic patients and the normoxemic groups.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age ≥ 18 years
-Non-emergent CABG surgery
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
-hemodynamic parameters (SVRI and C.I.) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During operation and ICU stay |
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E.5.2 | 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)
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E.5.2.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Different fractions of oxygen (standard therapy) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial: when 50 patients have been included |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |