Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial
IMPORTANCE: International resuscitation guidelines recommend targeted temperature management (TTM) at 33°C to 36°C in unconscious patients with out-of-hospital cardiac arrest for at least 24 hours, but the optimal duration of TTM is uncertain. OBJECTIVE: To determine whether TTM at 33°C for 48 hours...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2017-07, Vol.318 (4), p.341-350 |
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| creator | Kirkegaard, Hans Søreide, Eldar de Haas, Inge Pettilä, Ville Taccone, Fabio Silvio Arus, Urmet Storm, Christian Hassager, Christian Nielsen, Jørgen Feldbæk Sørensen, Christina Ankjær Ilkjær, Susanne Jeppesen, Anni Nørgaard Grejs, Anders Morten Duez, Christophe Henri Valdemar Hjort, Jakob Larsen, Alf Inge Toome, Valdo Tiainen, Marjaana Hästbacka, Johanna Laitio, Timo Skrifvars, Markus B |
| description | IMPORTANCE: International resuscitation guidelines recommend targeted temperature management (TTM) at 33°C to 36°C in unconscious patients with out-of-hospital cardiac arrest for at least 24 hours, but the optimal duration of TTM is uncertain. OBJECTIVE: To determine whether TTM at 33°C for 48 hours results in better neurologic outcomes compared with currently recommended, standard, 24-hour TTM. DESIGN, SETTING, AND PARTICIPANTS: This was an international, investigator-initiated, blinded-outcome-assessor, parallel, pragmatic, multicenter, randomized clinical superiority trial in 10 intensive care units (ICUs) at 10 university hospitals in 6 European countries. Three hundred fifty-five adult, unconscious patients with out-of-hospital cardiac arrest were enrolled from February 16, 2013, to June 1, 2016, with final follow-up on December 27, 2016. INTERVENTIONS: Patients were randomized to TTM (33 ± 1°C) for 48 hours (n = 176) or 24 hours (n = 179), followed by gradual rewarming of 0.5°C per hour until reaching 37°C. MAIN OUTCOMES AND MEASURES: The primary outcome was 6-month neurologic outcome, with a Cerebral Performance Categories (CPC) score of 1 or 2 used to define favorable outcome. Secondary outcomes included 6-month mortality, including time to death, the occurrence of adverse events, and intensive care unit resource use. RESULTS: In 355 patients who were randomized (mean age, 60 years; 295 [83%] men), 351 (99%) completed the trial. Of these patients, 69% (120/175) in the 48-hour group had a favorable outcome at 6 months compared with 64% (112/176) in the 24-hour group (difference, 4.9%; 95% CI, −5% to 14.8%; relative risk [RR], 1.08; 95% CI, 0.93-1.25; P = .33). Six-month mortality was 27% (48/175) in the 48-hour group and 34% (60/177) in the 24-hour group (difference, −6.5%; 95% CI, −16.1% to 3.1%; RR, 0.81; 95% CI, 0.59-1.11; P = .19). There was no significant difference in the time to mortality between the 48-hour group and the 24-hour group (hazard ratio, 0.79; 95% CI, 0.54-1.15; P = .22). Adverse events were more common in the 48-hour group (97%) than in the 24-hour group (91%) (difference, 5.6%; 95% CI, 0.6%-10.6%; RR, 1.06; 95% CI, 1.01-1.12; P = .04). The median length of intensive care unit stay (151 vs 117 hours; P |
| doi_str_mv | 10.1001/jama.2017.8978 |
| format | Article |
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OBJECTIVE: To determine whether TTM at 33°C for 48 hours results in better neurologic outcomes compared with currently recommended, standard, 24-hour TTM. DESIGN, SETTING, AND PARTICIPANTS: This was an international, investigator-initiated, blinded-outcome-assessor, parallel, pragmatic, multicenter, randomized clinical superiority trial in 10 intensive care units (ICUs) at 10 university hospitals in 6 European countries. Three hundred fifty-five adult, unconscious patients with out-of-hospital cardiac arrest were enrolled from February 16, 2013, to June 1, 2016, with final follow-up on December 27, 2016. INTERVENTIONS: Patients were randomized to TTM (33 ± 1°C) for 48 hours (n = 176) or 24 hours (n = 179), followed by gradual rewarming of 0.5°C per hour until reaching 37°C. MAIN OUTCOMES AND MEASURES: The primary outcome was 6-month neurologic outcome, with a Cerebral Performance Categories (CPC) score of 1 or 2 used to define favorable outcome. Secondary outcomes included 6-month mortality, including time to death, the occurrence of adverse events, and intensive care unit resource use. RESULTS: In 355 patients who were randomized (mean age, 60 years; 295 [83%] men), 351 (99%) completed the trial. Of these patients, 69% (120/175) in the 48-hour group had a favorable outcome at 6 months compared with 64% (112/176) in the 24-hour group (difference, 4.9%; 95% CI, −5% to 14.8%; relative risk [RR], 1.08; 95% CI, 0.93-1.25; P = .33). Six-month mortality was 27% (48/175) in the 48-hour group and 34% (60/177) in the 24-hour group (difference, −6.5%; 95% CI, −16.1% to 3.1%; RR, 0.81; 95% CI, 0.59-1.11; P = .19). There was no significant difference in the time to mortality between the 48-hour group and the 24-hour group (hazard ratio, 0.79; 95% CI, 0.54-1.15; P = .22). Adverse events were more common in the 48-hour group (97%) than in the 24-hour group (91%) (difference, 5.6%; 95% CI, 0.6%-10.6%; RR, 1.06; 95% CI, 1.01-1.12; P = .04). The median length of intensive care unit stay (151 vs 117 hours; P < .001), but not hospital stay (11 vs 12 days; P = .50), was longer in the 48-hour group than in the 24-hour group. CONCLUSIONS AND RELEVANCE: In unconscious survivors from out-of-hospital cardiac arrest admitted to the ICU, targeted temperature management at 33°C for 48 hours did not significantly improve 6-month neurologic outcome compared with targeted temperature management at 33°C for 24 hours. However, the study may have had limited power to detect clinically important differences, and further research may be warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01689077</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2017.8978</identifier><identifier>PMID: 28742911</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adults ; Aged ; Body Temperature ; Brain Diseases - etiology ; Cardiac arrest ; Cardiopulmonary Resuscitation - methods ; Caring for the Critically Ill Patient ; Clinical outcomes ; Clinical trials ; Design standards ; Female ; Heart ; Heart diseases ; Hospitals ; Humans ; Hypothermia, Induced - adverse effects ; Intensive care ; Intensive care units ; Male ; Management ; Middle Aged ; Morality ; Mortality ; Neurology ; Original Investigation ; Out-of-Hospital Cardiac Arrest - complications ; Out-of-Hospital Cardiac Arrest - mortality ; Out-of-Hospital Cardiac Arrest - therapy ; Patients ; Resuscitation ; Statistical analysis ; Temperature effects ; Time Factors ; Unconsciousness - etiology</subject><ispartof>JAMA : the journal of the American Medical Association, 2017-07, Vol.318 (4), p.341-350</ispartof><rights>Copyright American Medical Association Jul 25, 2017</rights><rights>Copyright 2017 American Medical Association. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.2017.8978$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.8978$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76458,76461</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28742911$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kirkegaard, Hans</creatorcontrib><creatorcontrib>Søreide, Eldar</creatorcontrib><creatorcontrib>de Haas, Inge</creatorcontrib><creatorcontrib>Pettilä, Ville</creatorcontrib><creatorcontrib>Taccone, Fabio Silvio</creatorcontrib><creatorcontrib>Arus, Urmet</creatorcontrib><creatorcontrib>Storm, Christian</creatorcontrib><creatorcontrib>Hassager, Christian</creatorcontrib><creatorcontrib>Nielsen, Jørgen Feldbæk</creatorcontrib><creatorcontrib>Sørensen, Christina Ankjær</creatorcontrib><creatorcontrib>Ilkjær, Susanne</creatorcontrib><creatorcontrib>Jeppesen, Anni Nørgaard</creatorcontrib><creatorcontrib>Grejs, Anders Morten</creatorcontrib><creatorcontrib>Duez, Christophe Henri Valdemar</creatorcontrib><creatorcontrib>Hjort, Jakob</creatorcontrib><creatorcontrib>Larsen, Alf Inge</creatorcontrib><creatorcontrib>Toome, Valdo</creatorcontrib><creatorcontrib>Tiainen, Marjaana</creatorcontrib><creatorcontrib>Hästbacka, Johanna</creatorcontrib><creatorcontrib>Laitio, Timo</creatorcontrib><creatorcontrib>Skrifvars, Markus B</creatorcontrib><title>Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>IMPORTANCE: International resuscitation guidelines recommend targeted temperature management (TTM) at 33°C to 36°C in unconscious patients with out-of-hospital cardiac arrest for at least 24 hours, but the optimal duration of TTM is uncertain. OBJECTIVE: To determine whether TTM at 33°C for 48 hours results in better neurologic outcomes compared with currently recommended, standard, 24-hour TTM. DESIGN, SETTING, AND PARTICIPANTS: This was an international, investigator-initiated, blinded-outcome-assessor, parallel, pragmatic, multicenter, randomized clinical superiority trial in 10 intensive care units (ICUs) at 10 university hospitals in 6 European countries. Three hundred fifty-five adult, unconscious patients with out-of-hospital cardiac arrest were enrolled from February 16, 2013, to June 1, 2016, with final follow-up on December 27, 2016. INTERVENTIONS: Patients were randomized to TTM (33 ± 1°C) for 48 hours (n = 176) or 24 hours (n = 179), followed by gradual rewarming of 0.5°C per hour until reaching 37°C. MAIN OUTCOMES AND MEASURES: The primary outcome was 6-month neurologic outcome, with a Cerebral Performance Categories (CPC) score of 1 or 2 used to define favorable outcome. Secondary outcomes included 6-month mortality, including time to death, the occurrence of adverse events, and intensive care unit resource use. RESULTS: In 355 patients who were randomized (mean age, 60 years; 295 [83%] men), 351 (99%) completed the trial. Of these patients, 69% (120/175) in the 48-hour group had a favorable outcome at 6 months compared with 64% (112/176) in the 24-hour group (difference, 4.9%; 95% CI, −5% to 14.8%; relative risk [RR], 1.08; 95% CI, 0.93-1.25; P = .33). Six-month mortality was 27% (48/175) in the 48-hour group and 34% (60/177) in the 24-hour group (difference, −6.5%; 95% CI, −16.1% to 3.1%; RR, 0.81; 95% CI, 0.59-1.11; P = .19). There was no significant difference in the time to mortality between the 48-hour group and the 24-hour group (hazard ratio, 0.79; 95% CI, 0.54-1.15; P = .22). Adverse events were more common in the 48-hour group (97%) than in the 24-hour group (91%) (difference, 5.6%; 95% CI, 0.6%-10.6%; RR, 1.06; 95% CI, 1.01-1.12; P = .04). The median length of intensive care unit stay (151 vs 117 hours; P < .001), but not hospital stay (11 vs 12 days; P = .50), was longer in the 48-hour group than in the 24-hour group. CONCLUSIONS AND RELEVANCE: In unconscious survivors from out-of-hospital cardiac arrest admitted to the ICU, targeted temperature management at 33°C for 48 hours did not significantly improve 6-month neurologic outcome compared with targeted temperature management at 33°C for 24 hours. However, the study may have had limited power to detect clinically important differences, and further research may be warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01689077</description><subject>Adults</subject><subject>Aged</subject><subject>Body Temperature</subject><subject>Brain Diseases - etiology</subject><subject>Cardiac arrest</subject><subject>Cardiopulmonary Resuscitation - methods</subject><subject>Caring for the Critically Ill Patient</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Design standards</subject><subject>Female</subject><subject>Heart</subject><subject>Heart diseases</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hypothermia, Induced - adverse effects</subject><subject>Intensive care</subject><subject>Intensive care units</subject><subject>Male</subject><subject>Management</subject><subject>Middle Aged</subject><subject>Morality</subject><subject>Mortality</subject><subject>Neurology</subject><subject>Original Investigation</subject><subject>Out-of-Hospital Cardiac Arrest - complications</subject><subject>Out-of-Hospital Cardiac Arrest - mortality</subject><subject>Out-of-Hospital Cardiac Arrest - therapy</subject><subject>Patients</subject><subject>Resuscitation</subject><subject>Statistical analysis</subject><subject>Temperature effects</subject><subject>Time Factors</subject><subject>Unconsciousness - etiology</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkc1uEzEUhS1ERdPClgULZIkNmwn-jW0WlaKIkkqFSiisrRuPJziaGQd7phK8Ql-6HqVEgDeWdb9z7OOD0GtK5pQQ-mEPHcwZoWqujdLP0IxKrisujX6OZoQYXSmhxTm6yHlPyqJcvUDnTCvBDKUz9LCBtPODr_HGdwefYBiTx1-gh53vfD_gJiYsNL7PmAm8jmPKGPoaf_Vjim3cBYfvxsHFzuNlM_g0narYVOuYD2GAFq8g1QEcXqbk8_ARL_G3oo9d-F3uXLWhD65QmxSgfYnOGmizf_W0X6Lv1582q3V1e_f5ZrW8rYBLNlRyazj3zImabzUDULWjjVo4I6lySuqFllAL4YnmiujacdALw4WQvFHOCMUv0dXR9zBuO1-7EjNBaw8pdJB-2QjB_jvpww-7i_dWSkE5E8Xg_ZNBij_HEst2ITvfttD7OGZLDeNKcKkn9N1_6L78YV_iFUoQSbVkulDzI-VSzDn55vQYSuzUs516tlPPduq5CN7-HeGE_ym2AG-OwKQ7TRdCUiL5I5YtrHY</recordid><startdate>20170725</startdate><enddate>20170725</enddate><creator>Kirkegaard, Hans</creator><creator>Søreide, Eldar</creator><creator>de Haas, Inge</creator><creator>Pettilä, Ville</creator><creator>Taccone, Fabio Silvio</creator><creator>Arus, Urmet</creator><creator>Storm, Christian</creator><creator>Hassager, Christian</creator><creator>Nielsen, Jørgen Feldbæk</creator><creator>Sørensen, Christina Ankjær</creator><creator>Ilkjær, Susanne</creator><creator>Jeppesen, Anni Nørgaard</creator><creator>Grejs, Anders Morten</creator><creator>Duez, Christophe Henri Valdemar</creator><creator>Hjort, Jakob</creator><creator>Larsen, Alf Inge</creator><creator>Toome, Valdo</creator><creator>Tiainen, Marjaana</creator><creator>Hästbacka, Johanna</creator><creator>Laitio, Timo</creator><creator>Skrifvars, Markus B</creator><general>American Medical Association</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>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20170725</creationdate><title>Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial</title><author>Kirkegaard, Hans ; Søreide, Eldar ; de Haas, Inge ; Pettilä, Ville ; Taccone, Fabio Silvio ; Arus, Urmet ; Storm, Christian ; Hassager, Christian ; Nielsen, Jørgen Feldbæk ; Sørensen, Christina Ankjær ; Ilkjær, Susanne ; Jeppesen, Anni Nørgaard ; Grejs, Anders Morten ; Duez, Christophe Henri Valdemar ; Hjort, Jakob ; Larsen, Alf Inge ; Toome, Valdo ; Tiainen, Marjaana ; Hästbacka, Johanna ; Laitio, Timo ; Skrifvars, Markus B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a352t-5b933e2c4d3b82aa7dc1f76c9517c758685ad44e083708dc3a86934453f7c9473</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adults</topic><topic>Aged</topic><topic>Body Temperature</topic><topic>Brain Diseases - etiology</topic><topic>Cardiac arrest</topic><topic>Cardiopulmonary Resuscitation - methods</topic><topic>Caring for the Critically Ill Patient</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Design standards</topic><topic>Female</topic><topic>Heart</topic><topic>Heart diseases</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hypothermia, Induced - adverse effects</topic><topic>Intensive care</topic><topic>Intensive care units</topic><topic>Male</topic><topic>Management</topic><topic>Middle Aged</topic><topic>Morality</topic><topic>Mortality</topic><topic>Neurology</topic><topic>Original Investigation</topic><topic>Out-of-Hospital Cardiac Arrest - complications</topic><topic>Out-of-Hospital Cardiac Arrest - mortality</topic><topic>Out-of-Hospital Cardiac Arrest - therapy</topic><topic>Patients</topic><topic>Resuscitation</topic><topic>Statistical analysis</topic><topic>Temperature effects</topic><topic>Time Factors</topic><topic>Unconsciousness - etiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kirkegaard, Hans</creatorcontrib><creatorcontrib>Søreide, Eldar</creatorcontrib><creatorcontrib>de Haas, Inge</creatorcontrib><creatorcontrib>Pettilä, Ville</creatorcontrib><creatorcontrib>Taccone, Fabio Silvio</creatorcontrib><creatorcontrib>Arus, Urmet</creatorcontrib><creatorcontrib>Storm, Christian</creatorcontrib><creatorcontrib>Hassager, Christian</creatorcontrib><creatorcontrib>Nielsen, Jørgen Feldbæk</creatorcontrib><creatorcontrib>Sørensen, Christina Ankjær</creatorcontrib><creatorcontrib>Ilkjær, Susanne</creatorcontrib><creatorcontrib>Jeppesen, Anni Nørgaard</creatorcontrib><creatorcontrib>Grejs, Anders Morten</creatorcontrib><creatorcontrib>Duez, Christophe Henri Valdemar</creatorcontrib><creatorcontrib>Hjort, Jakob</creatorcontrib><creatorcontrib>Larsen, Alf Inge</creatorcontrib><creatorcontrib>Toome, Valdo</creatorcontrib><creatorcontrib>Tiainen, Marjaana</creatorcontrib><creatorcontrib>Hästbacka, Johanna</creatorcontrib><creatorcontrib>Laitio, Timo</creatorcontrib><creatorcontrib>Skrifvars, Markus B</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kirkegaard, Hans</au><au>Søreide, Eldar</au><au>de Haas, Inge</au><au>Pettilä, Ville</au><au>Taccone, Fabio Silvio</au><au>Arus, Urmet</au><au>Storm, Christian</au><au>Hassager, Christian</au><au>Nielsen, Jørgen Feldbæk</au><au>Sørensen, Christina Ankjær</au><au>Ilkjær, Susanne</au><au>Jeppesen, Anni Nørgaard</au><au>Grejs, Anders Morten</au><au>Duez, Christophe Henri Valdemar</au><au>Hjort, Jakob</au><au>Larsen, Alf Inge</au><au>Toome, Valdo</au><au>Tiainen, Marjaana</au><au>Hästbacka, Johanna</au><au>Laitio, Timo</au><au>Skrifvars, Markus B</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2017-07-25</date><risdate>2017</risdate><volume>318</volume><issue>4</issue><spage>341</spage><epage>350</epage><pages>341-350</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><abstract>IMPORTANCE: International resuscitation guidelines recommend targeted temperature management (TTM) at 33°C to 36°C in unconscious patients with out-of-hospital cardiac arrest for at least 24 hours, but the optimal duration of TTM is uncertain. OBJECTIVE: To determine whether TTM at 33°C for 48 hours results in better neurologic outcomes compared with currently recommended, standard, 24-hour TTM. DESIGN, SETTING, AND PARTICIPANTS: This was an international, investigator-initiated, blinded-outcome-assessor, parallel, pragmatic, multicenter, randomized clinical superiority trial in 10 intensive care units (ICUs) at 10 university hospitals in 6 European countries. Three hundred fifty-five adult, unconscious patients with out-of-hospital cardiac arrest were enrolled from February 16, 2013, to June 1, 2016, with final follow-up on December 27, 2016. INTERVENTIONS: Patients were randomized to TTM (33 ± 1°C) for 48 hours (n = 176) or 24 hours (n = 179), followed by gradual rewarming of 0.5°C per hour until reaching 37°C. MAIN OUTCOMES AND MEASURES: The primary outcome was 6-month neurologic outcome, with a Cerebral Performance Categories (CPC) score of 1 or 2 used to define favorable outcome. Secondary outcomes included 6-month mortality, including time to death, the occurrence of adverse events, and intensive care unit resource use. RESULTS: In 355 patients who were randomized (mean age, 60 years; 295 [83%] men), 351 (99%) completed the trial. Of these patients, 69% (120/175) in the 48-hour group had a favorable outcome at 6 months compared with 64% (112/176) in the 24-hour group (difference, 4.9%; 95% CI, −5% to 14.8%; relative risk [RR], 1.08; 95% CI, 0.93-1.25; P = .33). Six-month mortality was 27% (48/175) in the 48-hour group and 34% (60/177) in the 24-hour group (difference, −6.5%; 95% CI, −16.1% to 3.1%; RR, 0.81; 95% CI, 0.59-1.11; P = .19). There was no significant difference in the time to mortality between the 48-hour group and the 24-hour group (hazard ratio, 0.79; 95% CI, 0.54-1.15; P = .22). Adverse events were more common in the 48-hour group (97%) than in the 24-hour group (91%) (difference, 5.6%; 95% CI, 0.6%-10.6%; RR, 1.06; 95% CI, 1.01-1.12; P = .04). The median length of intensive care unit stay (151 vs 117 hours; P < .001), but not hospital stay (11 vs 12 days; P = .50), was longer in the 48-hour group than in the 24-hour group. CONCLUSIONS AND RELEVANCE: In unconscious survivors from out-of-hospital cardiac arrest admitted to the ICU, targeted temperature management at 33°C for 48 hours did not significantly improve 6-month neurologic outcome compared with targeted temperature management at 33°C for 24 hours. However, the study may have had limited power to detect clinically important differences, and further research may be warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01689077</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>28742911</pmid><doi>10.1001/jama.2017.8978</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0098-7484 |
| ispartof | JAMA : the journal of the American Medical Association, 2017-07, Vol.318 (4), p.341-350 |
| issn | 0098-7484 1538-3598 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5541324 |
| source | MEDLINE; American Medical Association Journals |
| subjects | Adults Aged Body Temperature Brain Diseases - etiology Cardiac arrest Cardiopulmonary Resuscitation - methods Caring for the Critically Ill Patient Clinical outcomes Clinical trials Design standards Female Heart Heart diseases Hospitals Humans Hypothermia, Induced - adverse effects Intensive care Intensive care units Male Management Middle Aged Morality Mortality Neurology Original Investigation Out-of-Hospital Cardiac Arrest - complications Out-of-Hospital Cardiac Arrest - mortality Out-of-Hospital Cardiac Arrest - therapy Patients Resuscitation Statistical analysis Temperature effects Time Factors Unconsciousness - etiology |
| title | Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial |
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