Hypothermia versus Normothermia after Out-of-Hospital Cardiac ArrestLund Univ, Sweden.
Skane Univ Hosp, Sweden.
Univ Gothenburg, Sweden.
Univ Hosp Wales, Wales.
Lausanne Univ Hosp, Switzerland; Lausanne Univ Hosp, Switzerland; Univ Lausanne, Switzerland.
Descartes Univ Paris, France; Cochin Univ Hosp, France.
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South Western Sydney Local Hlth Dist, Australia; South Western Sydney Local Hlth Dist, Australia.
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Univ Pittsburgh, PA USA.
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Karolinska Inst, Sweden.
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Monash Univ, Australia; Monash Univ, Australia; Univ Coll Dublin, Ireland.
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Univ Gothenburg, Sweden.
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Essex Cardiothorac Ctr, England; Anglia Ruskin Univ, England.
Essex Cardiothorac Ctr, England; Anglia Ruskin Univ, England.
Kantonsspital St Gallen, Switzerland.
Kantonsspital St Gallen, Switzerland.
Charles Univ Prague, Czech Republic.
Charles Univ Prague, Czech Republic; Charles Univ Prague, Czech Republic.
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Univ Hosp Zurich, Switzerland.
Descartes Univ Paris, France; Cochin Univ Hosp, France.
Univ Hosp Wales, Wales.
Charles Univ Prague, Czech Republic; Charles Univ Prague, Czech Republic.
Lund Univ, Sweden.
Charite, Germany.
Lausanne Univ Hosp, Switzerland; Lausanne Univ Hosp, Switzerland; Univ Lausanne, Switzerland.
Wellington Hosp, New Zealand.
Helsingborg Hosp, Sweden.
Hallands Hosp, Sweden.
Univ Genoa, Italy.
Karolinska Inst, Sweden.
Royal Victoria Hosp, North Ireland.
Sorlandet Hosp, Norway.
Inst Cardioctr Ticino, Switzerland.
Dupuytren Teaching Hosp, France.
Norwegian Univ Sci & Technol, Norway; Norwegian Univ Sci & Technol, Norway.
Univ Copenhagen, Denmark.
Skane Univ Hosp Malmo, Sweden.
Helsingborg Hosp, Sweden; Helsingborg Hosp, Sweden.
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2021 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 384, no 24, p. 2283-2294Article in journal (Refereed) Published
Abstract [en]
Hypothermia or Normothermia after Cardiac Arrest This trial randomly assigned patients with coma after out-of-hospital cardiac arrest to undergo targeted hypothermia at 33 degrees C or normothermia with treatment of fever. At 6 months, there were no significant between-group differences regarding death or functional outcomes. Background Targeted temperature management is recommended for patients after cardiac arrest, but the supporting evidence is of low certainty. Methods In an open-label trial with blinded assessment of outcomes, we randomly assigned 1900 adults with coma who had had an out-of-hospital cardiac arrest of presumed cardiac or unknown cause to undergo targeted hypothermia at 33 degrees C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, >= 37.8 degrees C). The primary outcome was death from any cause at 6 months. Secondary outcomes included functional outcome at 6 months as assessed with the modified Rankin scale. Prespecified subgroups were defined according to sex, age, initial cardiac rhythm, time to return of spontaneous circulation, and presence or absence of shock on admission. Prespecified adverse events were pneumonia, sepsis, bleeding, arrhythmia resulting in hemodynamic compromise, and skin complications related to the temperature management device. Results A total of 1850 patients were evaluated for the primary outcome. At 6 months, 465 of 925 patients (50%) in the hypothermia group had died, as compared with 446 of 925 (48%) in the normothermia group (relative risk with hypothermia, 1.04; 95% confidence interval [CI], 0.94 to 1.14; P=0.37). Of the 1747 patients in whom the functional outcome was assessed, 488 of 881 (55%) in the hypothermia group had moderately severe disability or worse (modified Rankin scale score >= 4), as compared with 479 of 866 (55%) in the normothermia group (relative risk with hypothermia, 1.00; 95% CI, 0.92 to 1.09). Outcomes were consistent in the prespecified subgroups. Arrhythmia resulting in hemodynamic compromise was more common in the hypothermia group than in the normothermia group (24% vs. 17%, P<0.001). The incidence of other adverse events did not differ significantly between the two groups. Conclusions In patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not lead to a lower incidence of death by 6 months than targeted normothermia. (Funded by the Swedish Research Council and others; TTM2 ClinicalTrials.gov number, .)
Place, publisher, year, edition, pages
MASSACHUSETTS MEDICAL SOC , 2021. Vol. 384, no 24, p. 2283-2294
National Category
Anesthesiology and Intensive Care
Identifiers
URN: urn:nbn:se:liu:diva-177849DOI: 10.1056/NEJMoa2100591ISI: 000663653100012PubMedID: 34133859OAI: oai:DiVA.org:liu-177849DiVA, id: diva2:1578072
Note
Funding Agencies|Hjart-Lungfonden [2014-0774] Funding Source: Medline; Vetenskapsradet [2017-02627, 2016-00428] Funding Source: Medline
2021-07-052021-07-052021-07-05