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A Multicenter, Randomized, Controlled Phase IIb Trial of Avoidance of Hyperoxemia during Cardiopulmonary Bypass
Shay P McGuinness1, Rachael L Parke, Kate Drummond
1From the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand (S.P.M., R.L.P.); Medical Research Institute of New Zealand, Wellington, New Zealand (S.P.M., R.L.P.); ANZIC-Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia (S.P.M., R.L.P., M.B.); Royal Adelaide Hospital, Adelaide, South Australia (K.D.); Clinical Perfusion, Green Lane Cardiothoracic Surgical Unit, Auckland City Hospital, Auckland, New Zealand (T.W.); and Department of Anaesthesiology, University of Auckland, Auckland, New Zealand (T.W.)Auckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandCalvary Wakefield Hospital, Adelaide, South Australia.
Insights
Avoiding arterial hyperoxemia during cardiopulmonary bypass (CPB) did not reduce acute kidney injury (AKI) or other organ damage in cardiac surgery patients. This intervention did not impact mechanical ventilation duration or hospital stay.
Area of Science:
- Cardiology
- Critical Care Medicine
- Nephrology
Background:
- Cardiac surgery with cardiopulmonary bypass (CPB) is common.
- Cardiac surgery-associated multiorgan dysfunction (CSA-MOD) includes acute kidney injury (AKI), hepatic, myocardial, and neurologic damage.
- CPB-induced oxidative stress and reactive iron species contribute to CSA-MOD.
Purpose of the Study:
- To determine if avoiding arterial hyperoxemia during CPB decreases oxidative stress.
- To assess if avoiding arterial hyperoxemia reduces CSA-MOD severity in cardiac surgery patients.
Main Methods:
- Multicenter, open-label, randomized controlled study.
- Compared avoidance of arterial hyperoxemia versus usual care in CPB patients.
- Primary outcome: incidence and severity of AKI; Secondary outcomes: CSA-MOD biomarkers, ventilation duration, and length of stay.
Main Results:
- 298 patients randomized; mean PaO2 differed between groups during CPB.
- No significant difference in AKI incidence (72.0% vs. 66.2%).
- No difference in other organ damage markers or length of intensive care and hospital stay.
Conclusions:
- Avoiding modest arterial hyperoxemia during CPB did not reduce AKI.
- The intervention showed no benefit in reducing organ damage markers or length of stay.
Background:
Cardiac surgery utilizing cardiopulmonary bypass (CPB) is one of the most common forms of major surgery. Cardiac surgery-associated multiorgan dysfunction (CSA-MOD) is well recognized and includes acute kidney injury (AKI), hepatic impairment, myocardial damage, and postoperative neurologic deficit. Pathophysiology of CSA-MOD involves numerous injurious pathways linked to the use of CPB including oxidative stress and formation of reactive iron species. During cardiac surgery with CPB, arterial return blood is oxygenated to supranormal levels. This study aimed to determine whether the avoidance of arterial hyperoxemia decreased oxidative stress and reduced the severity of the multiorgan dysfunction in patients undergoing cardiac surgery utilizing CPB.
Methods:
The study was a multicenter, open-label, parallel-group, randomized controlled study of the avoidance of arterial hyperoxemia versus usual care in patients undergoing cardiac surgery involving CPB. Primary outcome was the incidence and severity of AKI. Secondary outcomes included serum biomarkers for CSA-MOD, duration of mechanical ventilation, and length of intensive care and hospital stay.
Results:
A total of 298 patients were randomized and analyzed at two hospitals in New Zealand and Australia. Mean PaO2 was significantly different between groups during CPB. There was no difference in the development of AKI (intervention arm 72.0% vs. usual care 66.2%; difference, -5.8% [95% CI, -16.1 to 4.7%]; P = 0.28), other markers of organ damage, or intensive care unit and hospital length of stay.
Conclusions:
Avoiding modest hyperoxemia during CPB failed to demonstrate any difference in AKI, markers of organ damage, or length of stay.
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