Osama Abou-Arab1,2, Pierre Huette3, Lucie Martineau3, Clémence Beauvalot4, Christophe Beyls3, Estelle Josse5, Gilles Touati6, Olivier Bouchot7, Belaïd Bouhemad4, Momar Diouf5, Emmanuel Lorne3, Pierre-Grégoire Guinot4. 1. Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France. osama.abouarab@gmail.com. 2. MP3CV, EA7517, CURS, Jules Verne University of Picardy, 80054, Amiens, France. osama.abouarab@gmail.com. 3. Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France. 4. Department of Anesthesiology and Critical Care Medicine, Dijon University Hospital, 14033, Dijon, France. 5. Department of Clinical Research, Amiens Picardy University Hospital, 80054, Amiens, France. 6. Department of Cardiac Surgery, Amiens Picardy University Hospital, 80054, Amiens, France. 7. Department of Cardiac Surgery, Dijon University Hospital, 14033, Dijon, France.
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.
RCT Entities:
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.
Authors: Robin Hofmann; Stefan K James; Tomas Jernberg; Bertil Lindahl; David Erlinge; Nils Witt; Gabriel Arefalk; Mats Frick; Joakim Alfredsson; Lennart Nilsson; Annica Ravn-Fischer; Elmir Omerovic; Thomas Kellerth; David Sparv; Ulf Ekelund; Rickard Linder; Mattias Ekström; Jörg Lauermann; Urban Haaga; John Pernow; Ollie Östlund; Johan Herlitz; Leif Svensson Journal: N Engl J Med Date: 2017-08-28 Impact factor: 91.245
Authors: Richard S D'Agostino; Jeffrey P Jacobs; Vinay Badhwar; Felix G Fernandez; Gaetano Paone; David W Wormuth; David M Shahian Journal: Ann Thorac Surg Date: 2018-01 Impact factor: 4.330
Authors: S F Aranki; D P Shaw; D H Adams; R J Rizzo; G S Couper; M VanderVliet; J J Collins; L H Cohn; H R Burstin Journal: Circulation Date: 1996-08-01 Impact factor: 29.690
Authors: Ib Jammer; Nadine Wickboldt; Michael Sander; Andrew Smith; Marcus J Schultz; Paolo Pelosi; Brigitte Leva; Andrew Rhodes; Andreas Hoeft; Bernhard Walder; Michelle S Chew; Rupert M Pearse Journal: Eur J Anaesthesiol Date: 2015-02 Impact factor: 4.330
Authors: Bob Smit; Yvo M Smulders; Monique C de Waard; Christa Boer; Alexander B A Vonk; Dennis Veerhoek; Suzanne Kamminga; Harm-Jan S de Grooth; Juan J García-Vallejo; Rene J P Musters; Armand R J Girbes; Heleen M Oudemans-van Straaten; Angelique M E Spoelstra-de Man Journal: Crit Care Date: 2016-03-10 Impact factor: 9.097
Authors: Anthony Calhoun; Ameeka Pannu; Ariel L Mueller; Omar Elmadhoun; Juan D Valencia; Megan L Krajewski; Brian P O'Gara; Anastasia Katsiampoura; Sean T O'Connor; Louis Chu; Erika Monteith; Puja Shankar; Kyle Spear; Shahzad Shaefi Journal: J Cardiothorac Vasc Anesth Date: 2022-01-19 Impact factor: 2.894
Authors: Shahzad Shaefi; Puja Shankar; Ariel L Mueller; Brian P O'Gara; Kyle Spear; Kamal R Khabbaz; Aranya Bagchi; Louis M Chu; Valerie Banner-Goodspeed; David E Leaf; Daniel S Talmor; Edward R Marcantonio; Balachundhar Subramaniam Journal: Anesthesiology Date: 2021-02-01 Impact factor: 7.892