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Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial

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 t...

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Published in:Intensive care medicine 2019-10, Vol.45 (10), p.1413-1421
Main Authors: Abou-Arab, Osama, Huette, Pierre, Martineau, Lucie, Beauvalot, Clémence, Beyls, Christophe, Josse, Estelle, Touati, Gilles, Bouchot, Olivier, Bouhemad, Belaïd, Diouf, Momar, Lorne, Emmanuel, Guinot, Pierre-Grégoire
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cited_by cdi_FETCH-LOGICAL-c514t-58e3bbfca6de5a038fc50edcee293f8f4e033bbffb5b39c625f86a185f9be1743
cites cdi_FETCH-LOGICAL-c514t-58e3bbfca6de5a038fc50edcee293f8f4e033bbffb5b39c625f86a185f9be1743
container_end_page 1421
container_issue 10
container_start_page 1413
container_title Intensive care medicine
container_volume 45
creator Abou-Arab, Osama
Huette, Pierre
Martineau, Lucie
Beauvalot, Clémence
Beyls, Christophe
Josse, Estelle
Touati, Gilles
Bouchot, Olivier
Bouhemad, Belaïd
Diouf, Momar
Lorne, Emmanuel
Guinot, Pierre-Grégoire
description 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 PaO 2 was 447 ± 98 mmHg and 161 ± 60 mmHg during CPB, for the intervention and standard group ( p  
doi_str_mv 10.1007/s00134-019-05761-4
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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 PaO 2 was 447 ± 98 mmHg and 161 ± 60 mmHg during CPB, for the intervention and standard group ( p  &lt; 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.</description><identifier>ISSN: 0342-4642</identifier><identifier>EISSN: 1432-1238</identifier><identifier>DOI: 10.1007/s00134-019-05761-4</identifier><identifier>PMID: 31576438</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Aged ; Anesthesiology ; Atrial fibrillation ; Atrial Fibrillation - epidemiology ; Atrial Fibrillation - etiology ; Biological Physics ; Blood pressure ; Cardiac arrhythmia ; Cardiac Surgical Procedures - methods ; Cardiopulmonary Bypass - methods ; Cardiopulmonary Bypass - standards ; Cardiopulmonary Bypass - statistics &amp; numerical data ; Cardiovascular diseases ; Cardiovascular Diseases - epidemiology ; Cardiovascular Diseases - etiology ; Cardiovascular Diseases - surgery ; Cerebral blood flow ; Clinical trials ; Complications ; Complications and side effects ; Coronary artery bypass ; Critical Care Medicine ; Emergency Medicine ; ESICM Lives Clinical Trials ; Evidence-based medicine ; Female ; Fibrillation ; France ; France - epidemiology ; Heart ; Heart surgery ; Hospitals ; Humans ; Hyperoxia ; Hyperoxia - complications ; Hyperoxia - physiopathology ; Incidence ; Intensive ; Intensive care ; Intervention ; Ischemia ; Male ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Morbidity ; Mortality ; Original ; Oxygen ; Oxygen - blood ; Oxygen - therapeutic use ; Pain Medicine ; Patients ; Pediatrics ; Physics ; Pneumology/Respiratory System ; Postoperative Complications - epidemiology ; Postoperative Complications - etiology ; Postoperative Period ; Reduction ; Reperfusion ; Risk management ; Surgery ; Tachycardia ; Ventricle ; Ventricular fibrillation</subject><ispartof>Intensive care medicine, 2019-10, Vol.45 (10), p.1413-1421</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019</rights><rights>COPYRIGHT 2019 Springer</rights><rights>Intensive Care Medicine is a copyright of Springer, (2019). All Rights Reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c514t-58e3bbfca6de5a038fc50edcee293f8f4e033bbffb5b39c625f86a185f9be1743</citedby><cites>FETCH-LOGICAL-c514t-58e3bbfca6de5a038fc50edcee293f8f4e033bbffb5b39c625f86a185f9be1743</cites><orcidid>0000-0003-3766-716X ; 0000-0002-7019-9727 ; 0000-0002-3016-6509 ; 0000-0001-8949-7348 ; 0000-0001-6409-5449</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31576438$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-03610582$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Abou-Arab, Osama</creatorcontrib><creatorcontrib>Huette, Pierre</creatorcontrib><creatorcontrib>Martineau, Lucie</creatorcontrib><creatorcontrib>Beauvalot, Clémence</creatorcontrib><creatorcontrib>Beyls, Christophe</creatorcontrib><creatorcontrib>Josse, Estelle</creatorcontrib><creatorcontrib>Touati, Gilles</creatorcontrib><creatorcontrib>Bouchot, Olivier</creatorcontrib><creatorcontrib>Bouhemad, Belaïd</creatorcontrib><creatorcontrib>Diouf, Momar</creatorcontrib><creatorcontrib>Lorne, Emmanuel</creatorcontrib><creatorcontrib>Guinot, Pierre-Grégoire</creatorcontrib><title>Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial</title><title>Intensive care medicine</title><addtitle>Intensive Care Med</addtitle><addtitle>Intensive Care Med</addtitle><description>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 PaO 2 was 447 ± 98 mmHg and 161 ± 60 mmHg during CPB, for the intervention and standard group ( p  &lt; 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.</description><subject>Aged</subject><subject>Anesthesiology</subject><subject>Atrial fibrillation</subject><subject>Atrial Fibrillation - epidemiology</subject><subject>Atrial Fibrillation - etiology</subject><subject>Biological Physics</subject><subject>Blood pressure</subject><subject>Cardiac arrhythmia</subject><subject>Cardiac Surgical Procedures - methods</subject><subject>Cardiopulmonary Bypass - methods</subject><subject>Cardiopulmonary Bypass - standards</subject><subject>Cardiopulmonary Bypass - statistics &amp; numerical data</subject><subject>Cardiovascular diseases</subject><subject>Cardiovascular Diseases - epidemiology</subject><subject>Cardiovascular Diseases - etiology</subject><subject>Cardiovascular Diseases - surgery</subject><subject>Cerebral blood flow</subject><subject>Clinical trials</subject><subject>Complications</subject><subject>Complications and side effects</subject><subject>Coronary artery bypass</subject><subject>Critical Care Medicine</subject><subject>Emergency Medicine</subject><subject>ESICM Lives Clinical Trials</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Fibrillation</subject><subject>France</subject><subject>France - epidemiology</subject><subject>Heart</subject><subject>Heart surgery</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hyperoxia</subject><subject>Hyperoxia - complications</subject><subject>Hyperoxia - physiopathology</subject><subject>Incidence</subject><subject>Intensive</subject><subject>Intensive care</subject><subject>Intervention</subject><subject>Ischemia</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine &amp; 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Huette, Pierre ; Martineau, Lucie ; Beauvalot, Clémence ; Beyls, Christophe ; Josse, Estelle ; Touati, Gilles ; Bouchot, Olivier ; Bouhemad, Belaïd ; Diouf, Momar ; Lorne, Emmanuel ; Guinot, Pierre-Grégoire</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c514t-58e3bbfca6de5a038fc50edcee293f8f4e033bbffb5b39c625f86a185f9be1743</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Anesthesiology</topic><topic>Atrial fibrillation</topic><topic>Atrial Fibrillation - epidemiology</topic><topic>Atrial Fibrillation - etiology</topic><topic>Biological Physics</topic><topic>Blood pressure</topic><topic>Cardiac arrhythmia</topic><topic>Cardiac Surgical Procedures - methods</topic><topic>Cardiopulmonary Bypass - methods</topic><topic>Cardiopulmonary Bypass - standards</topic><topic>Cardiopulmonary Bypass - statistics &amp; numerical data</topic><topic>Cardiovascular diseases</topic><topic>Cardiovascular Diseases - epidemiology</topic><topic>Cardiovascular Diseases - etiology</topic><topic>Cardiovascular Diseases - surgery</topic><topic>Cerebral blood flow</topic><topic>Clinical trials</topic><topic>Complications</topic><topic>Complications and side effects</topic><topic>Coronary artery bypass</topic><topic>Critical Care Medicine</topic><topic>Emergency Medicine</topic><topic>ESICM Lives Clinical Trials</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Fibrillation</topic><topic>France</topic><topic>France - epidemiology</topic><topic>Heart</topic><topic>Heart surgery</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hyperoxia</topic><topic>Hyperoxia - complications</topic><topic>Hyperoxia - physiopathology</topic><topic>Incidence</topic><topic>Intensive</topic><topic>Intensive care</topic><topic>Intervention</topic><topic>Ischemia</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Morbidity</topic><topic>Mortality</topic><topic>Original</topic><topic>Oxygen</topic><topic>Oxygen - blood</topic><topic>Oxygen - therapeutic use</topic><topic>Pain Medicine</topic><topic>Patients</topic><topic>Pediatrics</topic><topic>Physics</topic><topic>Pneumology/Respiratory System</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - etiology</topic><topic>Postoperative Period</topic><topic>Reduction</topic><topic>Reperfusion</topic><topic>Risk management</topic><topic>Surgery</topic><topic>Tachycardia</topic><topic>Ventricle</topic><topic>Ventricular fibrillation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Abou-Arab, Osama</creatorcontrib><creatorcontrib>Huette, Pierre</creatorcontrib><creatorcontrib>Martineau, Lucie</creatorcontrib><creatorcontrib>Beauvalot, Clémence</creatorcontrib><creatorcontrib>Beyls, Christophe</creatorcontrib><creatorcontrib>Josse, Estelle</creatorcontrib><creatorcontrib>Touati, Gilles</creatorcontrib><creatorcontrib>Bouchot, Olivier</creatorcontrib><creatorcontrib>Bouhemad, Belaïd</creatorcontrib><creatorcontrib>Diouf, Momar</creatorcontrib><creatorcontrib>Lorne, Emmanuel</creatorcontrib><creatorcontrib>Guinot, Pierre-Grégoire</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Intensive care medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Abou-Arab, Osama</au><au>Huette, Pierre</au><au>Martineau, Lucie</au><au>Beauvalot, Clémence</au><au>Beyls, Christophe</au><au>Josse, Estelle</au><au>Touati, Gilles</au><au>Bouchot, Olivier</au><au>Bouhemad, Belaïd</au><au>Diouf, Momar</au><au>Lorne, Emmanuel</au><au>Guinot, Pierre-Grégoire</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial</atitle><jtitle>Intensive care medicine</jtitle><stitle>Intensive Care Med</stitle><addtitle>Intensive Care Med</addtitle><date>2019-10-01</date><risdate>2019</risdate><volume>45</volume><issue>10</issue><spage>1413</spage><epage>1421</epage><pages>1413-1421</pages><issn>0342-4642</issn><eissn>1432-1238</eissn><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 PaO 2 was 447 ± 98 mmHg and 161 ± 60 mmHg during CPB, for the intervention and standard group ( p  &lt; 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.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31576438</pmid><doi>10.1007/s00134-019-05761-4</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-3766-716X</orcidid><orcidid>https://orcid.org/0000-0002-7019-9727</orcidid><orcidid>https://orcid.org/0000-0002-3016-6509</orcidid><orcidid>https://orcid.org/0000-0001-8949-7348</orcidid><orcidid>https://orcid.org/0000-0001-6409-5449</orcidid></addata></record>
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subjects Aged
Anesthesiology
Atrial fibrillation
Atrial Fibrillation - epidemiology
Atrial Fibrillation - etiology
Biological Physics
Blood pressure
Cardiac arrhythmia
Cardiac Surgical Procedures - methods
Cardiopulmonary Bypass - methods
Cardiopulmonary Bypass - standards
Cardiopulmonary Bypass - statistics & numerical data
Cardiovascular diseases
Cardiovascular Diseases - epidemiology
Cardiovascular Diseases - etiology
Cardiovascular Diseases - surgery
Cerebral blood flow
Clinical trials
Complications
Complications and side effects
Coronary artery bypass
Critical Care Medicine
Emergency Medicine
ESICM Lives Clinical Trials
Evidence-based medicine
Female
Fibrillation
France
France - epidemiology
Heart
Heart surgery
Hospitals
Humans
Hyperoxia
Hyperoxia - complications
Hyperoxia - physiopathology
Incidence
Intensive
Intensive care
Intervention
Ischemia
Male
Medicine
Medicine & Public Health
Middle Aged
Morbidity
Mortality
Original
Oxygen
Oxygen - blood
Oxygen - therapeutic use
Pain Medicine
Patients
Pediatrics
Physics
Pneumology/Respiratory System
Postoperative Complications - epidemiology
Postoperative Complications - etiology
Postoperative Period
Reduction
Reperfusion
Risk management
Surgery
Tachycardia
Ventricle
Ventricular fibrillation
title Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial
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