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Hypothermia versus normothermia after out-of-hospital cardiac arrest

Dankiewicz, Josef LU orcid ; Cronberg, Tobias LU ; Lilja, Gisela LU ; Levin, Helena LU ; Ullén, Susann LU ; Erlinge, David LU orcid ; Düring, Joachim LU orcid ; Schmidbauer, Simon LU orcid ; Borgquist, Ola LU and Annborn, Martin LU , et al. (2021) In New England Journal of Medicine 384(24). p.2283-2294
Abstract
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°C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, ≥37.8°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... (More)
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°C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, ≥37.8°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 (Less)
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author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Aged, Body Temperature, Cardiopulmonary Resuscitation/methods, Coma/etiology, Female, Fever/etiology, Humans, Hypothermia, Induced/adverse effects, Kaplan-Meier Estimate, Male, Middle Aged, Out-of-Hospital Cardiac Arrest/complications, Single-Blind Method, Treatment Outcome
in
New England Journal of Medicine
volume
384
issue
24
pages
12 pages
publisher
Massachusetts Medical Society
external identifiers
  • scopus:85108262132
  • pmid:34133859
ISSN
0028-4793
DOI
10.1056/NEJMoa2100591
language
English
LU publication?
yes
id
6789b6e3-e50b-40b1-a3c9-e1a26d0f92ad
date added to LUP
2021-09-13 13:28:36
date last changed
2023-03-01 13:42:15
@article{6789b6e3-e50b-40b1-a3c9-e1a26d0f92ad,
  abstract     = {{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°C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, ≥37.8°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}},
  author       = {{Dankiewicz, Josef and Cronberg, Tobias and Lilja, Gisela and Levin, Helena and Ullén, Susann and Erlinge, David and Düring, Joachim and Schmidbauer, Simon and Borgquist, Ola and Annborn, Martin and Undén, Johan and Friberg, Hans and Nielsen, Niklas}},
  issn         = {{0028-4793}},
  keywords     = {{Aged; Body Temperature; Cardiopulmonary Resuscitation/methods; Coma/etiology; Female; Fever/etiology; Humans; Hypothermia, Induced/adverse effects; Kaplan-Meier Estimate; Male; Middle Aged; Out-of-Hospital Cardiac Arrest/complications; Single-Blind Method; Treatment Outcome}},
  language     = {{eng}},
  number       = {{24}},
  pages        = {{2283--2294}},
  publisher    = {{Massachusetts Medical Society}},
  series       = {{New England Journal of Medicine}},
  title        = {{Hypothermia versus normothermia after out-of-hospital cardiac arrest}},
  url          = {{http://dx.doi.org/10.1056/NEJMoa2100591}},
  doi          = {{10.1056/NEJMoa2100591}},
  volume       = {{384}},
  year         = {{2021}},
}