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Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): A randomized clinical trial - Rationale and design
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- Dankiewicz, Josef (författare)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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- Cronberg, Tobias (författare)
- Lund University,Lunds universitet,Brain Injury After Cardiac Arrest,Forskargrupper vid Lunds universitet,Lund University Research Groups,Skåne University Hospital
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- Lilja, Gisela (författare)
- Lund University,Lunds universitet,Brain Injury After Cardiac Arrest,Forskargrupper vid Lunds universitet,Lund University Research Groups,Skåne University Hospital
- visa fler...
- Callaway, C. (författare)
- Wise, M. P. (författare)
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- (creator_code:org_t)
- Elsevier BV, 2019
- 2019
- Engelska.
- Ingår i: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 217, s. 23-31
- Tidskriftsartikel (refereegranskat)
Abstract
Ämnesord
Stäng
- 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. © 2019
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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- ref (ämneskategori)
- art (ämneskategori)
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- Dankiewicz, Jose ...
- Cronberg, Tobias
- Lilja, Gisela
- Jakobsen, J. C.
- Bělohlávek, J.
- Callaway, C.
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- Cariou, A.
- Eastwood, G.
- Erlinge, David
- Hovdenes, J.
- Joannidis, M.
- Kirkegaard, H.
- Kuiper, M.
- Levin, Helena
- Morgan, M. P. G.
- Nichol, A. D.
- Nordberg, P.
- Oddo, M.
- Pelosi, P.
- Rylander, Christ ...
- Saxena, M.
- Storm, C.
- Taccone, F.
- Ullén, Susann
- Wise, M. P.
- Young, P.
- Friberg, Hans
- Nielsen, Niklas
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