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Target temperature management after out-of-hospital cardiac arrest-a randomized, parallel-group, assessor-blinded clinical trial-rationale and design

Nielsen, Niklas; Wetterslev, Jorn; al-Subaie, Nawaf; Andersson, Bertil; Bro-Jeppesen, John; Bishop, Gillian; Brunetti, Iole; Cranshaw, Julius; Cronberg, Tobias LU and Edqvist, Kristin, et al. (2012) In American Heart Journal 163(4). p.541-548
Abstract
Background Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32 degrees C to 34 degrees C for 12 to 24 hours after resuscitation from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia in the control groups. The optimal target temperature management strategy is not known. Methods The TTM trial is an... (More)
Background Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32 degrees C to 34 degrees C for 12 to 24 hours after resuscitation from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia in the control groups. The optimal target temperature management strategy is not known. Methods The TTM trial is an investigator-initiated, international, randomized, parallel-group, and assessor-blinded clinical trial designed to enroll at least 850 adult, unconscious patients resuscitated after out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized to a target temperature management of either 33 degrees C or 36 degrees C after return of spontaneous circulation. In both groups, the intervention will last 36 hours. The primary outcome is all-cause mortality at maximal follow-up. The main secondary outcomes are the composite outcome of all-cause mortality and poor neurologic function (cerebral performance categories 3 and 4) at hospital discharge and at 180 days, cognitive status and quality of life at 180 days, assessment of safety and harm. Discussion The TTM trial will investigate potential benefit and harm of 2 target temperature strategies, both avoiding hyperthermia in a large proportion of the out-of-hospital cardiac arrest population. (Am Heart J 2012; 163:541-8.) (Less)
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@article{c109c9e8-9c6d-40fd-ba17-2319431df44b,
  abstract     = {Background Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32 degrees C to 34 degrees C for 12 to 24 hours after resuscitation from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia in the control groups. The optimal target temperature management strategy is not known. Methods The TTM trial is an investigator-initiated, international, randomized, parallel-group, and assessor-blinded clinical trial designed to enroll at least 850 adult, unconscious patients resuscitated after out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized to a target temperature management of either 33 degrees C or 36 degrees C after return of spontaneous circulation. In both groups, the intervention will last 36 hours. The primary outcome is all-cause mortality at maximal follow-up. The main secondary outcomes are the composite outcome of all-cause mortality and poor neurologic function (cerebral performance categories 3 and 4) at hospital discharge and at 180 days, cognitive status and quality of life at 180 days, assessment of safety and harm. Discussion The TTM trial will investigate potential benefit and harm of 2 target temperature strategies, both avoiding hyperthermia in a large proportion of the out-of-hospital cardiac arrest population. (Am Heart J 2012; 163:541-8.)},
  author       = {Nielsen, Niklas and Wetterslev, Jorn and al-Subaie, Nawaf and Andersson, Bertil and Bro-Jeppesen, John and Bishop, Gillian and Brunetti, Iole and Cranshaw, Julius and Cronberg, Tobias and Edqvist, Kristin and Erlinge, David and Gasche, Yvan and Glover, Guy and Hassager, Christian and Horn, Janneke and Hovdenes, Jan and Johnsson, Jesper and Kjaergaard, Jesper and Kuiper, Michael and Langorgen, Jorund and Macken, Lewis and Martinell, Louise and Martner, Patrik and Pellis, Thomas and Pelosi, Paolo and Petersen, Per and Persson, Stefan and Rundgren, Malin and Saxena, Manoj and Svensson, Robert and Stammet, Pascal and Thoren, Anders and Unden, Johan and Walden, Andrew and Wallskog, Jesper and Wanscher, Michael and Wise, Matthew P. and Wyon, Nicholas and Aneman, Anders and Friberg, Hans},
  issn         = {1097-6744},
  language     = {eng},
  number       = {4},
  pages        = {541--548},
  publisher    = {Mosby},
  series       = {American Heart Journal},
  title        = {Target temperature management after out-of-hospital cardiac arrest-a randomized, parallel-group, assessor-blinded clinical trial-rationale and design},
  url          = {http://dx.doi.org/10.1016/j.ahj.2012.01.013},
  volume       = {163},
  year         = {2012},
}