TY - JOUR KW - Humans KW - Treatment Outcome KW - Research Design KW - Multicenter Studies as Topic KW - Randomized Controlled Trials as Topic KW - Body Temperature KW - Out-of-Hospital Cardiac Arrest KW - Quality of Life AU - Nielsen Niklas AU - Wetterslev Jørn AU - al-Subaie Nawaf AU - Andersson Bertil AU - Bro-Jeppesen John AU - Bishop Gillian AU - Brunetti Iole AU - Cranshaw Julius AU - Cronberg Tobias AU - Edqvist Kristin AU - Erlinge David AU - Gasche Yvan AU - Glover Guy AU - Hassager Christian AU - Horn Janneke AU - Hovdenes Jan AU - Johnsson Jesper AU - Kjaergaard Jesper AU - Kuiper Michael AU - Langørgen Jørund AU - Macken Lewis AU - Martinell Louise AU - Martner Patrik AU - Pellis Thomas AU - Pelosi Paolo AU - Petersen Per AU - Persson Stefan AU - Rundgren Malin AU - Svensson Robert AU - Stammet Pascal AU - Thorén Anders AU - Undén Johan AU - Walden Andrew AU - Wallskog Jesper AU - Wanscher Michael AU - Wise Matthew AU - Wyon Nicholas AU - Aneman Anders AU - Friberg Hans AU - M. Saxena AB -

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.

BT - American Heart Journal DO - 10.1016/j.ahj.2012.01.013 IS - 4 J2 - Am. Heart J. LA - eng N2 -

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.

PY - 2012 SP - 541 EP - 8 T2 - American Heart Journal TI - Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. VL - 163 SN - 1097-6744 ER -