The cardiovascular effects of hyperoxia during and after CABG surgery

Phase 4

Completed

Conditions: coronary bypass surgery (for coronary artery stenosis)
10011082

Registration Number: NL-OMON38987

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>-hemodynamics<br /><br>-microcirculation<br /><br>-oxidative stress<br /><br>-tissue/organ perfusion<br /><br>-clinical endpoints (duration of mechanical ventilation, length of stay,<br /><br>mortality).</p><br>