Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX)

Purpose Sepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis. Methods We undertook a...

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Veröffentlicht in:Intensive care medicine 2020-01, Vol.46 (1), p.17-26
Hauptverfasser: Young, Paul, Mackle, Diane, Bellomo, Rinaldo, Bailey, Michael, Beasley, Richard, Deane, Adam, Eastwood, Glenn, Finfer, Simon, Freebairn, Ross, King, Victoria, Linke, Natalie, Litton, Edward, McArthur, Colin, McGuinness, Shay, Panwar, Rakshit
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container_end_page 26
container_issue 1
container_start_page 17
container_title Intensive care medicine
container_volume 46
creator Young, Paul
Mackle, Diane
Bellomo, Rinaldo
Bailey, Michael
Beasley, Richard
Deane, Adam
Eastwood, Glenn
Finfer, Simon
Freebairn, Ross
King, Victoria
Linke, Natalie
Litton, Edward
McArthur, Colin
McGuinness, Shay
Panwar, Rakshit
description Purpose Sepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis. Methods We undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU. Results Patients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO 2  ≥ 97% (23.5 h [interquartile range (IQR) 8–70] vs. 47 h [IQR 11–93], absolute difference, 23 h; 95% CI 8–38), and more time receiving an FiO 2 of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1–79] vs. 0 h [IQR 0–10], absolute difference, 20 h; 95% CI 14–26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI − 4.6 to 18.6% points; P  = 0.24; interaction P  = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy. Conclusions Point estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group. Clinical Trials Registry ICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.
doi_str_mv 10.1007/s00134-019-05857-x
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Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis. Methods We undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU. Results Patients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO 2  ≥ 97% (23.5 h [interquartile range (IQR) 8–70] vs. 47 h [IQR 11–93], absolute difference, 23 h; 95% CI 8–38), and more time receiving an FiO 2 of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1–79] vs. 0 h [IQR 0–10], absolute difference, 20 h; 95% CI 14–26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI − 4.6 to 18.6% points; P  = 0.24; interaction P  = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy. Conclusions Point estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group. Clinical Trials Registry ICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.</description><identifier>ISSN: 0342-4642</identifier><identifier>EISSN: 1432-1238</identifier><identifier>DOI: 10.1007/s00134-019-05857-x</identifier><identifier>PMID: 31748836</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject><![CDATA[Adult ; Aged ; Anesthesiology ; Australia ; Care and treatment ; Clinical trials ; Comparative analysis ; Conservatism ; Conservative Treatment - methods ; Conservative Treatment - standards ; Conservative Treatment - statistics & numerical data ; Critical Care Medicine ; Emergency Medicine ; Female ; Health aspects ; Hospital patients ; Humans ; Infection ; Intensive ; Intensive care ; Intensive Care Units - organization & administration ; Intensive Care Units - statistics & numerical data ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Mortality ; New Zealand ; Original ; Oxygen ; Oxygen Inhalation Therapy - methods ; Oxygen Inhalation Therapy - standards ; Oxygen Inhalation Therapy - statistics & numerical data ; Oxygen therapy ; Pain Medicine ; Patients ; Pediatrics ; Pneumology/Respiratory System ; Respiration, Artificial - methods ; Respiration, Artificial - standards ; Respiration, Artificial - statistics & numerical data ; Respiratory therapy ; Sepsis ; Sepsis - physiopathology ; Sepsis - therapy ; Statistical analysis ; Therapy ; Treatment Outcome]]></subject><ispartof>Intensive care medicine, 2020-01, Vol.46 (1), p.17-26</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019</rights><rights>COPYRIGHT 2020 Springer</rights><rights>Intensive Care Medicine is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c579t-c03a4d34ca60b4002dbefdc36bacf229bb25c565b273369231058516fcdfad1e3</citedby><cites>FETCH-LOGICAL-c579t-c03a4d34ca60b4002dbefdc36bacf229bb25c565b273369231058516fcdfad1e3</cites><orcidid>0000-0002-3428-3083</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00134-019-05857-x$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00134-019-05857-x$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,776,780,881,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31748836$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Young, Paul</creatorcontrib><creatorcontrib>Mackle, Diane</creatorcontrib><creatorcontrib>Bellomo, Rinaldo</creatorcontrib><creatorcontrib>Bailey, Michael</creatorcontrib><creatorcontrib>Beasley, Richard</creatorcontrib><creatorcontrib>Deane, Adam</creatorcontrib><creatorcontrib>Eastwood, Glenn</creatorcontrib><creatorcontrib>Finfer, Simon</creatorcontrib><creatorcontrib>Freebairn, Ross</creatorcontrib><creatorcontrib>King, Victoria</creatorcontrib><creatorcontrib>Linke, Natalie</creatorcontrib><creatorcontrib>Litton, Edward</creatorcontrib><creatorcontrib>McArthur, Colin</creatorcontrib><creatorcontrib>McGuinness, Shay</creatorcontrib><creatorcontrib>Panwar, Rakshit</creatorcontrib><creatorcontrib>ICU-ROX Investigators the Australian New Zealand Intensive Care Society Clinical Trials Group</creatorcontrib><creatorcontrib>the ICU-ROX Investigators the Australian New Zealand Intensive Care Society Clinical Trials Group</creatorcontrib><title>Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX)</title><title>Intensive care medicine</title><addtitle>Intensive Care Med</addtitle><addtitle>Intensive Care Med</addtitle><description>Purpose Sepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis. Methods We undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU. Results Patients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO 2  ≥ 97% (23.5 h [interquartile range (IQR) 8–70] vs. 47 h [IQR 11–93], absolute difference, 23 h; 95% CI 8–38), and more time receiving an FiO 2 of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1–79] vs. 0 h [IQR 0–10], absolute difference, 20 h; 95% CI 14–26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI − 4.6 to 18.6% points; P  = 0.24; interaction P  = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy. Conclusions Point estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group. Clinical Trials Registry ICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.</description><subject>Adult</subject><subject>Aged</subject><subject>Anesthesiology</subject><subject>Australia</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Comparative analysis</subject><subject>Conservatism</subject><subject>Conservative Treatment - methods</subject><subject>Conservative Treatment - standards</subject><subject>Conservative Treatment - statistics &amp; numerical data</subject><subject>Critical Care Medicine</subject><subject>Emergency Medicine</subject><subject>Female</subject><subject>Health aspects</subject><subject>Hospital patients</subject><subject>Humans</subject><subject>Infection</subject><subject>Intensive</subject><subject>Intensive care</subject><subject>Intensive Care Units - organization &amp; administration</subject><subject>Intensive Care Units - statistics &amp; numerical data</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>New Zealand</subject><subject>Original</subject><subject>Oxygen</subject><subject>Oxygen Inhalation Therapy - methods</subject><subject>Oxygen Inhalation Therapy - standards</subject><subject>Oxygen Inhalation Therapy - statistics &amp; numerical data</subject><subject>Oxygen therapy</subject><subject>Pain Medicine</subject><subject>Patients</subject><subject>Pediatrics</subject><subject>Pneumology/Respiratory System</subject><subject>Respiration, Artificial - methods</subject><subject>Respiration, Artificial - standards</subject><subject>Respiration, Artificial - statistics &amp; numerical data</subject><subject>Respiratory therapy</subject><subject>Sepsis</subject><subject>Sepsis - physiopathology</subject><subject>Sepsis - therapy</subject><subject>Statistical analysis</subject><subject>Therapy</subject><subject>Treatment Outcome</subject><issn>0342-4642</issn><issn>1432-1238</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9ks1q3DAUhU1padK0L9BFEXSTLpzqx5Y9XQTC0J9AIFAa6E5cy_JYQZZcSZ7M9BH7VJU7adKEoWghuPrOueJwsuw1wScE4-p9wJiwIsdkkeOyLqt88yQ7JAWjOaGsfpodYlbQvOAFPchehHCd8IqX5Hl2wEhV1DXjh9mvpbNB-TVEvVbIbbYrZVHslYdxizrn0aBkD1ZLMGaL1spGbSCqFkE7mRjQjY49CmoMOnxAgEYXIuqdRGDBbNMQuQ61EAF13g2zMdI2KhvmbRK8QpPVEXmwrRv0z-QbvQaDpBtG8NquULxxCMbRO5C9Cii6x588Pl9e5V8vv797mT3rwAT16vY-yq4-ffy2_JJfXH4-X55d5LKsFjGXmEHRskICx02BMW0b1bWS8QZkR-miaWgpS142tGKMLygjc7iEd7LtoCWKHWWnO99xagbVypSJByNGrwfwW-FAi4cvVvdi5daiopTxukgGx7cG3v2YVIhi0EEqY8AqNwWRVvKqZolO6NtH6LWbfMp2pgpWMkI4v6dWYJTQtnNpr5xNxVmVqlAvKrpIVL6HSlGmHI2zqtNp_IA_2cOn06pBy70CuhNI70LwqrvLhGAxN1bsGitSY8WfxopNEr35N807yd-KJoDtgDDOhVD-PoL_2P4Gls_7Xw</recordid><startdate>20200101</startdate><enddate>20200101</enddate><creator>Young, Paul</creator><creator>Mackle, Diane</creator><creator>Bellomo, Rinaldo</creator><creator>Bailey, Michael</creator><creator>Beasley, Richard</creator><creator>Deane, Adam</creator><creator>Eastwood, Glenn</creator><creator>Finfer, Simon</creator><creator>Freebairn, Ross</creator><creator>King, Victoria</creator><creator>Linke, Natalie</creator><creator>Litton, Edward</creator><creator>McArthur, Colin</creator><creator>McGuinness, Shay</creator><creator>Panwar, Rakshit</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</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>5PM</scope><orcidid>https://orcid.org/0000-0002-3428-3083</orcidid></search><sort><creationdate>20200101</creationdate><title>Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX)</title><author>Young, Paul ; Mackle, Diane ; Bellomo, Rinaldo ; Bailey, Michael ; Beasley, Richard ; Deane, Adam ; Eastwood, Glenn ; Finfer, Simon ; Freebairn, Ross ; King, Victoria ; Linke, Natalie ; Litton, Edward ; McArthur, Colin ; McGuinness, Shay ; Panwar, Rakshit</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c579t-c03a4d34ca60b4002dbefdc36bacf229bb25c565b273369231058516fcdfad1e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anesthesiology</topic><topic>Australia</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Comparative analysis</topic><topic>Conservatism</topic><topic>Conservative Treatment - methods</topic><topic>Conservative Treatment - standards</topic><topic>Conservative Treatment - statistics &amp; numerical data</topic><topic>Critical Care Medicine</topic><topic>Emergency Medicine</topic><topic>Female</topic><topic>Health aspects</topic><topic>Hospital patients</topic><topic>Humans</topic><topic>Infection</topic><topic>Intensive</topic><topic>Intensive care</topic><topic>Intensive Care Units - organization &amp; administration</topic><topic>Intensive Care Units - statistics &amp; numerical data</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>New Zealand</topic><topic>Original</topic><topic>Oxygen</topic><topic>Oxygen Inhalation Therapy - methods</topic><topic>Oxygen Inhalation Therapy - standards</topic><topic>Oxygen Inhalation Therapy - statistics &amp; numerical data</topic><topic>Oxygen therapy</topic><topic>Pain Medicine</topic><topic>Patients</topic><topic>Pediatrics</topic><topic>Pneumology/Respiratory System</topic><topic>Respiration, Artificial - methods</topic><topic>Respiration, Artificial - standards</topic><topic>Respiration, Artificial - statistics &amp; numerical data</topic><topic>Respiratory therapy</topic><topic>Sepsis</topic><topic>Sepsis - physiopathology</topic><topic>Sepsis - therapy</topic><topic>Statistical analysis</topic><topic>Therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Young, Paul</creatorcontrib><creatorcontrib>Mackle, Diane</creatorcontrib><creatorcontrib>Bellomo, Rinaldo</creatorcontrib><creatorcontrib>Bailey, Michael</creatorcontrib><creatorcontrib>Beasley, Richard</creatorcontrib><creatorcontrib>Deane, Adam</creatorcontrib><creatorcontrib>Eastwood, Glenn</creatorcontrib><creatorcontrib>Finfer, Simon</creatorcontrib><creatorcontrib>Freebairn, Ross</creatorcontrib><creatorcontrib>King, Victoria</creatorcontrib><creatorcontrib>Linke, Natalie</creatorcontrib><creatorcontrib>Litton, Edward</creatorcontrib><creatorcontrib>McArthur, Colin</creatorcontrib><creatorcontrib>McGuinness, Shay</creatorcontrib><creatorcontrib>Panwar, Rakshit</creatorcontrib><creatorcontrib>ICU-ROX Investigators the Australian New Zealand Intensive Care Society Clinical Trials Group</creatorcontrib><creatorcontrib>the ICU-ROX Investigators the Australian New Zealand Intensive Care Society Clinical Trials Group</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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Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Nursing &amp; 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>PubMed Central (Full Participant titles)</collection><jtitle>Intensive care medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Young, Paul</au><au>Mackle, Diane</au><au>Bellomo, Rinaldo</au><au>Bailey, Michael</au><au>Beasley, Richard</au><au>Deane, Adam</au><au>Eastwood, Glenn</au><au>Finfer, Simon</au><au>Freebairn, Ross</au><au>King, Victoria</au><au>Linke, Natalie</au><au>Litton, Edward</au><au>McArthur, Colin</au><au>McGuinness, Shay</au><au>Panwar, Rakshit</au><aucorp>ICU-ROX Investigators the Australian New Zealand Intensive Care Society Clinical Trials Group</aucorp><aucorp>the ICU-ROX Investigators the Australian New Zealand Intensive Care Society Clinical Trials Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX)</atitle><jtitle>Intensive care medicine</jtitle><stitle>Intensive Care Med</stitle><addtitle>Intensive Care Med</addtitle><date>2020-01-01</date><risdate>2020</risdate><volume>46</volume><issue>1</issue><spage>17</spage><epage>26</epage><pages>17-26</pages><issn>0342-4642</issn><eissn>1432-1238</eissn><abstract>Purpose Sepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis. Methods We undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU. Results Patients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO 2  ≥ 97% (23.5 h [interquartile range (IQR) 8–70] vs. 47 h [IQR 11–93], absolute difference, 23 h; 95% CI 8–38), and more time receiving an FiO 2 of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1–79] vs. 0 h [IQR 0–10], absolute difference, 20 h; 95% CI 14–26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI − 4.6 to 18.6% points; P  = 0.24; interaction P  = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy. Conclusions Point estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group. Clinical Trials Registry ICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31748836</pmid><doi>10.1007/s00134-019-05857-x</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-3428-3083</orcidid><oa>free_for_read</oa></addata></record>
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source MEDLINE; Springer Nature - Complete Springer Journals
subjects Adult
Aged
Anesthesiology
Australia
Care and treatment
Clinical trials
Comparative analysis
Conservatism
Conservative Treatment - methods
Conservative Treatment - standards
Conservative Treatment - statistics & numerical data
Critical Care Medicine
Emergency Medicine
Female
Health aspects
Hospital patients
Humans
Infection
Intensive
Intensive care
Intensive Care Units - organization & administration
Intensive Care Units - statistics & numerical data
Male
Medicine
Medicine & Public Health
Middle Aged
Mortality
New Zealand
Original
Oxygen
Oxygen Inhalation Therapy - methods
Oxygen Inhalation Therapy - standards
Oxygen Inhalation Therapy - statistics & numerical data
Oxygen therapy
Pain Medicine
Patients
Pediatrics
Pneumology/Respiratory System
Respiration, Artificial - methods
Respiration, Artificial - standards
Respiration, Artificial - statistics & numerical data
Respiratory therapy
Sepsis
Sepsis - physiopathology
Sepsis - therapy
Statistical analysis
Therapy
Treatment Outcome
title Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX)
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