The cardiovascular effects of hyperoxia during and after CABG surgery

The cardiovascular effects of hyperoxia during and after CABG surgery - Cardiovascular effects of hyperoxia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38987

Enrollment

Registered

2013-05-17

Start date

2013-11-15

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary bypass surgery (for coronary artery stenosis)

Interventions

We will investigate current practice ( 1, 2

group I) with titrated oxygen levels (group II). group I: target PaO2 on CBP during aortic clamp time 200 * 220 mmHg, PaO2 at ICU of 130-150 mm Hg group II: : After intubation FiO2 will be decreased

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Age * 18 years -Non-emergent CABG surgery -Hb * 7.5 mmol/l -BSA * 1.9 m2

Exclusion criteria

Exclusion criteria: -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
Hemodynamic parameters: myocardial injury (CK-MB and hs-troponine-T) The primary endpoint was chosen because of its ability to provide proof-of-concept for the cardiovascular effects of hyperoxia. If indeed myocardial injury is found, a variety of secondary endpoints may support the relevance this has for hemodynamics, organ perfusion, etc. Effects on clinical endpoints, such as length-of-stay, mortality, etc, can only be anticipated to show-up in much larger clinical trials.If indeed hyperoxia shows unfavourable effects on most hemodynamic, perfusion-related and metabolic endpoints, such large trials are unlikely to ever be performed.	—

Measure

Time frame

Hemodynamic parameters: myocardial injury (CK-MB and hs-troponine-T) The primary endpoint was chosen because of its ability to provide proof-of-concept for the cardiovascular effects of hyperoxia. If indeed myocardial injury is found, a variety of secondary endpoints may support the relevance this has for hemodynamics, organ perfusion, etc. Effects on clinical endpoints, such as length-of-stay, mortality, etc, can only be anticipated to show-up in much larger clinical trials.If indeed hyperoxia shows unfavourable effects on most hemodynamic, perfusion-related and metabolic endpoints, such large trials are unlikely to ever be performed.

—

Secondary

Measure	Time frame
-hemodynamics -microcirculation -oxidative stress -tissue/organ perfusion -clinical endpoints (duration of mechanical ventilation, length of stay, mortality).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)