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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 |
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container_title | Intensive care medicine |
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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 |
format | article |
fullrecord | <record><control><sourceid>gale_hal_p</sourceid><recordid>TN_cdi_hal_primary_oai_HAL_hal_03610582v1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A724266874</galeid><sourcerecordid>A724266874</sourcerecordid><originalsourceid>FETCH-LOGICAL-c514t-58e3bbfca6de5a038fc50edcee293f8f4e033bbffb5b39c625f86a185f9be1743</originalsourceid><addsrcrecordid>eNp9kl-L1DAUxYso7rj6BXyQgC_60DV_mjb1bRj_zMLAgij4FtL0ZjZL2tSkXR2_iF_XdGecRRkkDxcuv3PIuZwse07wBcG4ehMxJqzIMalzzKuS5MWDbEEKRnNCmXiYLTAraF6UBT3LnsR4k_Cq5ORxdsZI4gsmFtmv9W6A4H9Yhdop2H6LtAqt9cPkOt-rsEPNblAxotZDRL0fUQs6gIpwAG9V1JNTAWnfDc5qNVrfR2S8c_770U9pFKewhbB7i8ZrQKvlp3eXV19RUH3rO_sTWqSd7ZPcoTFY5Z5mj4xyEZ4d5nn25cP7z6t1vrn6eLlabnLNSTHmXABrGqNV2QJXmAmjOYZWA9CaGWEKwGwGTMMbVuuSciNKRQQ3dQOkKth59nrve62cHILtUmTplZXr5UbOO8xKgrmgtySxr_bsEPy3CeIoOxs1OKd68FOUlKULi5qIGX35D3rjp9CnJJLSui4rUVF-T22VA2l748eg9GwqlxUtaFmKuy_mJ6gt9BCU8z0Ym9Z_8Rcn-PRa6Kw-KaB7gQ4-xgDmeAiC5dw0uW-aTE2Td02Ts-jFIeHUdNAeJX-qlQC2B-Iw9wrC_Qn-Y_sbjjzfkg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2299678725</pqid></control><display><type>article</type><title>Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial</title><source>Springer Nature</source><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</creator><creatorcontrib>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</creatorcontrib><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
< 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 & 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</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
< 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 & 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 & Public Health</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Original</subject><subject>Oxygen</subject><subject>Oxygen - blood</subject><subject>Oxygen - therapeutic use</subject><subject>Pain Medicine</subject><subject>Patients</subject><subject>Pediatrics</subject><subject>Physics</subject><subject>Pneumology/Respiratory System</subject><subject>Postoperative Complications - epidemiology</subject><subject>Postoperative Complications - etiology</subject><subject>Postoperative Period</subject><subject>Reduction</subject><subject>Reperfusion</subject><subject>Risk management</subject><subject>Surgery</subject><subject>Tachycardia</subject><subject>Ventricle</subject><subject>Ventricular fibrillation</subject><issn>0342-4642</issn><issn>1432-1238</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp9kl-L1DAUxYso7rj6BXyQgC_60DV_mjb1bRj_zMLAgij4FtL0ZjZL2tSkXR2_iF_XdGecRRkkDxcuv3PIuZwse07wBcG4ehMxJqzIMalzzKuS5MWDbEEKRnNCmXiYLTAraF6UBT3LnsR4k_Cq5ORxdsZI4gsmFtmv9W6A4H9Yhdop2H6LtAqt9cPkOt-rsEPNblAxotZDRL0fUQs6gIpwAG9V1JNTAWnfDc5qNVrfR2S8c_770U9pFKewhbB7i8ZrQKvlp3eXV19RUH3rO_sTWqSd7ZPcoTFY5Z5mj4xyEZ4d5nn25cP7z6t1vrn6eLlabnLNSTHmXABrGqNV2QJXmAmjOYZWA9CaGWEKwGwGTMMbVuuSciNKRQQ3dQOkKth59nrve62cHILtUmTplZXr5UbOO8xKgrmgtySxr_bsEPy3CeIoOxs1OKd68FOUlKULi5qIGX35D3rjp9CnJJLSui4rUVF-T22VA2l748eg9GwqlxUtaFmKuy_mJ6gt9BCU8z0Ym9Z_8Rcn-PRa6Kw-KaB7gQ4-xgDmeAiC5dw0uW-aTE2Td02Ts-jFIeHUdNAeJX-qlQC2B-Iw9wrC_Qn-Y_sbjjzfkg</recordid><startdate>20191001</startdate><enddate>20191001</enddate><creator>Abou-Arab, Osama</creator><creator>Huette, Pierre</creator><creator>Martineau, Lucie</creator><creator>Beauvalot, Clémence</creator><creator>Beyls, Christophe</creator><creator>Josse, Estelle</creator><creator>Touati, Gilles</creator><creator>Bouchot, Olivier</creator><creator>Bouhemad, Belaïd</creator><creator>Diouf, Momar</creator><creator>Lorne, Emmanuel</creator><creator>Guinot, Pierre-Grégoire</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><general>Springer Verlag</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>1XC</scope><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></search><sort><creationdate>20191001</creationdate><title>Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial</title><author>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</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 & 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 & 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 & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Biochemistry Abstracts 1</collection><collection>Nursing & 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
< 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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ispartof | Intensive care medicine, 2019-10, Vol.45 (10), p.1413-1421 |
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language | eng |
recordid | cdi_hal_primary_oai_HAL_hal_03610582v1 |
source | Springer Nature |
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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