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

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

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.)

Detaljer

Författare
  • Niklas Nielsen
  • Jorn Wetterslev
  • Nawaf al-Subaie
  • Bertil Andersson
  • John Bro-Jeppesen
  • Gillian Bishop
  • Iole Brunetti
  • Julius Cranshaw
  • Kristin Edqvist
  • Yvan Gasche
  • Guy Glover
  • Christian Hassager
  • Janneke Horn
  • Jan Hovdenes
  • Jesper Johnsson
  • Jesper Kjaergaard
  • Michael Kuiper
  • Jorund Langorgen
  • Lewis Macken
  • Louise Martinell
  • Patrik Martner
  • Thomas Pellis
  • Paolo Pelosi
  • Per Petersen
  • Stefan Persson
  • Malin Rundgren
  • Manoj Saxena
  • Robert Svensson
  • Pascal Stammet
  • Anders Thoren
  • Johan Unden
  • Andrew Walden
  • Jesper Wallskog
  • Michael Wanscher
  • Matthew P. Wise
  • Nicholas Wyon
  • Anders Aneman
Enheter & grupper
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Kardiologi
Originalspråkengelska
Sidor (från-till)541-548
TidskriftAmerican Heart Journal
Volym163
Utgåva nummer4
StatusPublished - 2012
PublikationskategoriForskning
Peer review utfördJa