@article{20587,
  keywords = {Humans, Treatment Outcome, Research Design, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Body Temperature, Out-of-Hospital Cardiac Arrest, Quality of Life},
  author = {Nielsen Niklas and Wetterslev Jørn 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 Langørgen Jørund 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 Svensson Robert and Stammet Pascal and Thorén Anders and Undén Johan and Walden Andrew and Wallskog Jesper and Wanscher Michael and Wise Matthew and Wyon Nicholas and Aneman Anders and Friberg Hans and M. Saxena},
  title = {Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design.},
  abstract = {<p>
<b>BACKGROUND: </b>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°C to 34°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.
</p>

<p>
<b>METHODS: </b>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°C or 36°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.
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<p>
<b>DISCUSSION: </b>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.
</p>
},
  year = {2012},
  journal = {American Heart Journal},
  volume = {163},
  pages = {541-8},
  issn = {1097-6744},
  doi = {10.1016/j.ahj.2012.01.013},
  language = {eng},
}