TY - JOUR

T1 - Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest

AU - Dankiewicz, Josef

AU - Cronberg, Tobias

AU - Lilja, Gisela

AU - Jakobsen, Janus C.

AU - Levin, Helena

AU - Ullen, Susann

AU - Rylander, Christian

AU - Wise, Matt P.

AU - Oddo, Mauro

AU - Cariou, Alain

AU - Belohlavek, Jan

AU - Hovdenes, Jan

AU - Saxena, Manoj

AU - Kirkegaard, Hans

AU - Young, Paul J.

AU - Pelosi, Paolo

AU - Storm, Christian

AU - Taccone, Fabio S.

AU - Joannidis, Michael

AU - Callaway, Clifton

AU - Eastwood, Glenn M.

AU - Morgan, Matt P. G.

AU - Nordberg, Per

AU - Erlinge, David

AU - Nichol, Alistair D.

AU - Chew, Michelle S.

AU - Hollenberg, Jacob

AU - Thomas, Matthew

AU - Bewley, Jeremy

AU - Sweet, Katie

AU - Grejs, Anders M.

AU - Christensen, Steffen

AU - Haenggi, Matthias

AU - Levis, Anja

AU - Lundin, Andreas

AU - During, Joachim

AU - Schmidbauer, Simon

AU - Keeble, Thomas R.

AU - Karamasis, Grigoris V.

AU - Schrag, Claudia

AU - Faessler, Edith

AU - Smid, Ondrej

AU - Otahal, Michal

AU - Maggiorini, Marco

AU - Wendel Garcia, Pedro D.

AU - Jaubert, Paul

AU - Cole, Jade M.

AU - Solar, Miroslav

AU - Lange, Theis

AU - Nielsen, Niklas

AU - TTM2 Trial Invest

PY - 2021

Y1 - 2021

N2 - Hypothermia or Normothermia after Cardiac ArrestThis 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.BackgroundTargeted temperature management is recommended for patients after cardiac arrest, but the supporting evidence is of low certainty.MethodsIn 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.ResultsA 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%, PConclusionsIn 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, .)

AB - Hypothermia or Normothermia after Cardiac ArrestThis 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.BackgroundTargeted temperature management is recommended for patients after cardiac arrest, but the supporting evidence is of low certainty.MethodsIn 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.ResultsA 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%, PConclusionsIn 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, .)

KW - TARGETED TEMPERATURE MANAGEMENT

KW - EUROPEAN RESUSCITATION COUNCIL

KW - AMERICAN-HEART-ASSOCIATION

KW - CARDIOPULMONARY-RESUSCITATION

KW - GUIDELINES

U2 - 10.1056/NEJMoa2100591

DO - 10.1056/NEJMoa2100591

M3 - Journal article

C2 - 34133859

VL - 384

SP - 2283

EP - 2294

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 24

ER -