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Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): A randomized clinical trial-Rationale and design
J. Dankiewicz, T. Cronberg, G. Lilja, JC. Jakobsen, J. Bělohlávek, C. Callaway, A. Cariou, G. Eastwood, D. Erlinge, J. Hovdenes, M. Joannidis, H. Kirkegaard, M. Kuiper, H. Levin, MPG. Morgan, AD. Nichol, P. Nordberg, M. Oddo, P. Pelosi, C....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu protokol klinické studie, časopisecké články
NLK
ProQuest Central
od 2002-01-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health & Medicine (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health Management Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Public Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
- MeSH
- časové faktory MeSH
- hodnocení ekvivalence jako téma * MeSH
- hodnocení výsledků zdravotní péče MeSH
- horečka terapie MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- příčina smrti MeSH
- randomizované kontrolované studie jako téma * MeSH
- tělesná teplota * MeSH
- terapeutická hypotermie metody MeSH
- velikost vzorku MeSH
- zástava srdce mimo nemocnici mortalita terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
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.
Adult Critical Care University Hospital of Wales Cardiff United Kingdom
Clinical Studies Sweden Skåne University Hospital Lund Sweden
Department of Anesthesia and Intensive Care Oslo University Hospital Rikshospitalet Oslo Norway
Department of Emergency Medicine University of Pittsburgh Pittsburgh PA USA
Department of Intensive Care Austin Hospital Heidelberg Australia
Department of Intensive Care Medical Center Leeuwarden Leeuwarden Netherlands
Department of Research and Education Lund University and Skåne University Hospital
Lund University Skåne University Hospital Department of Clinical Sciences Cardiology Lund Sweden
Lund University Skåne University Hospital Department of Clinical Sciences Neurology Lund Sweden
Medical Intensive Care Unit Cochin University Hospital and Paris Descartes University Paris France
Medical Research Institute of New Zealand Wellington New Zealand
Section of Cardiology Stockholm South General Hospital Stockholm Sweden
University College Dublin Clinical Research Centre St Vincent's University Hospital Dublin Ireland
Citace poskytuje Crossref.org
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- $a Dankiewicz, Josef $u Lund University, Skåne University Hospital, Department of Clinical Sciences, Cardiology, Lund, Sweden. Electronic address: josef.dankiewicz@med.lu.se.
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- $a 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.
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