Abstract
Purpose
Data on the benefit or or harmful effects of oxygen level on ischemic reperfusion injuries in cardiac surgery are insufficient. We hypothesized that hyperoxia during cardiopulmonary bypass decreases the incidence of postoperative atrial fibrillation (POAF) and ventricular fibrillation, and therefore decreases cardiovascular morbidity (CARDIOX study).
Methods
An open-label, randomized clinical trial including adults undergoing elective cardiac surgery, i.e. cardiopulmonary bypass (CPB) randomized 1:1 to an intervention group or standard group at two French University Hospitals from June 2016 to October 2018. The intervention consisted in delivering of an inspired fraction of oxygen of one to one during CPB. The standard care consisted in delivering oxygen to achieve a partial arterial blood pressure less than 150 mmHg. The primary endpoint was the occurrence of POAF and/or ventricular tachycardia/ventricular fibrillation (VT/VF) within the 15 days following cardiac surgery. The secondary endpoint was the occurrence of major adverse cardiovascular events (MACCE: in-hospital mortality, stroke, cardiac arrest, acute kidney injury, and mesenteric ischemia).
Results
330 patients were randomly assigned to either the intervention group (n = 161) or the standard group (n = 163). Mean PaO2 was 447 ± 98 mmHg and 161 ± 60 mmHg during CPB, for the intervention and standard group (p < 0.0001) respectively. The incidence of POAF or VT/VF were similar in the intervention group and the standard group (30% [49 of 161 patients] and 30% [49 of 163 patients], absolute risk reduction 0.4%; 95% CI, − 9.6–10.4; p = 0.94). MACCE was similar between groups with, an occurrence of 24% and 21% for the intervention group and the standard groups (absolute risk reduction 3.4%; 95% CI, − 5.7–12.5; p = 0.47) respectively. After adjustment, the primary and secondary endpoints remained similar for both groups.
Conclusion
Hyperoxia did not decrease POAF and cardiovascular morbidity following cardiac surgery with CPB.
Clinicaltrial.gov identifier
NCT02819739.
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Acknowledgements
Data were collected by representatives of Clinical Research Divisions of Amiens (Estelle Josse) and Dijon University Hospital (Clémence Beauvalot). The first draft of the manuscript was written by Dr Osama Abou-Arab, Dr Pierre Huette and Pr Pierre-Grégoire Guinot with review and revision by the others authors. Statistical analysis was performed by Mr Momar Diouf. The authors would like to thank CARDIOX participating centers: Centre hospitalier universitaire de Picardie (Yazine Mahjoub, MD, PhD; Mathieu Guilbart, MD; Patricia Besserve, MD; Beatris Labont, MD; Abdel Hchikat, MD; Amar Ben-Ammar, MD; Hervé Dupont, MD, PhD; Thierry Caus, MD, PhD; Jean-Paul Remadi, MD) and Centre hospitalier universitaire de Dijon (Anis Missaoui, MD; Omar Ellouze, MD; Tiberiu Constandache, MD; Sandrine Grosjean, MD; Vivien Berthoud, MD; Jean-Philippe Parthiot, MD; Jean-Pierre Merle, MD).
Funding
The study was sponsored by Amiens University Hospital.
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OAA: study design, performing the procedure, writing the first manuscript and revising the manuscript; PH: study design, performing the procedure and revising the manuscript; PGG: study design, performing the procedure, and revising the manuscript; MD: statistical analysis; EL: study design and revising the manuscript; CB: performing the procedure; EJ: data collection; CB: performing the procedure; all the authors: revision and final approval of the version to be submitted.
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This study was conducted in accordance with the Declaration of Helsinki and was approved by the local research ethics committee.
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Abou-Arab, O., Huette, P., Martineau, L. et al. Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial. Intensive Care Med 45, 1413–1421 (2019). https://doi.org/10.1007/s00134-019-05761-4
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DOI: https://doi.org/10.1007/s00134-019-05761-4