03627nas a2200685 4500000000100000008004100001653001100042653002200053653002000075653003300095653004200128653002100170653003500191653002000226100001900246700002100265700002000286700002100306700002200327700001900349700001800368700002000386700002000406700002000426700001800446700001600464700001500480700002300495700001700518700001700535700002000552700002200572700001900594700002300613700001700636700002100653700001900674700001800693700001700711700001700728700001900745700001900764700002000783700001900803700001900822700001700841700001800858700002000876700002100896700001700917700001800934700001800952700001700970700001400987245015701001300001001158490000801168520175101176022001402927 2012 d 10 aHumans 10 aTreatment Outcome 10 aResearch Design 10 aMulticenter Studies as Topic 10 aRandomized Controlled Trials as Topic 10 aBody Temperature 10 aOut-of-Hospital Cardiac Arrest 10 aQuality of Life 1 aNielsen Niklas 1 aWetterslev Jørn 1 aal-Subaie Nawaf 1 aAndersson Bertil 1 aBro-Jeppesen John 1 aBishop Gillian 1 aBrunetti Iole 1 aCranshaw Julius 1 aCronberg Tobias 1 aEdqvist Kristin 1 aErlinge David 1 aGasche Yvan 1 aGlover Guy 1 aHassager Christian 1 aHorn Janneke 1 aHovdenes Jan 1 aJohnsson Jesper 1 aKjaergaard Jesper 1 aKuiper Michael 1 aLangørgen Jørund 1 aMacken Lewis 1 aMartinell Louise 1 aMartner Patrik 1 aPellis Thomas 1 aPelosi Paolo 1 aPetersen Per 1 aPersson Stefan 1 aRundgren Malin 1 aSvensson Robert 1 aStammet Pascal 1 aThorén Anders 1 aUndén Johan 1 aWalden Andrew 1 aWallskog Jesper 1 aWanscher Michael 1 aWise Matthew 1 aWyon Nicholas 1 aAneman Anders 1 aFriberg Hans 1 aM. Saxena 00 aTarget Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. a541-8 0 v163 3 a
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°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.
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°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.
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.
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