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Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): A randomized clinical trial-Rationale and design

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  • Josef Dankiewicz
  • Tobias Cronberg
  • Gisela Lilja
  • Janus Christian Jakobsen
  • Jan Bělohlávek
  • Clifton Callaway
  • Alain Cariou
  • Glenn Eastwood
  • David Erlinge
  • Jan Hovdenes
  • Michael Joannidis
  • Hans Kirkegaard
  • Michael Kuiper
  • Helena Levin
  • Matt P G Morgan
  • Alistair D Nichol
  • Per Nordberg
  • Mauro Oddo
  • Paolo Pelosi
  • Christian Rylander
  • Manoj Saxena
  • Christian Storm
  • Fabio Taccone
  • Susann Ullén
  • Matthew P Wise
  • Paul Young
  • Hans Friberg
  • Niklas Nielsen
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BACKGROUND: Less than 500 participants have been included in randomized trials comparing hypothermia with regular care for out-of-hospital cardiac arrest patients, and many of these trials were small and at a high risk of bias. Consequently, the accrued data on this potentially beneficial intervention resembles that of a drug following small phase II trials. A large confirmatory trial is therefore warranted.

METHODS: The TTM2-trial is an international, multicenter, parallel group, investigator-initiated, randomized, superiority trial in which a target temperature of 33°C after cardiac arrest will be compared with a strategy to maintain normothermia and early treatment of fever (≥37.8°C). Participants will be randomized within 3 hours of return of spontaneous circulation with the intervention period lasting 40 hours in both groups. Sedation will be mandatory for all patients throughout the intervention period. The clinical team involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention. Prognosticators, outcome-assessors, the steering group, the trial coordinating team, and trial statistician will be blinded. The primary outcome will be all-cause mortality at 180 days after randomization. We estimate a 55% mortality in the control group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4-6) at 180 days after arrest.

DISCUSSION: The TTM2-trial will compare hypothermia to 33°C with normothermia and early treatment of fever (≥37.8°C) after out-of-hospital cardiac arrest.

OriginalsprogEngelsk
TidsskriftAmerican Heart Journal
Vol/bind217
Sider (fra-til)23-31
Antal sider9
ISSN0002-8703
DOI
StatusUdgivet - 26 jun. 2019

Bibliografisk note

Copyright © 2019. Published by Elsevier Inc.

ID: 58262274