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Protocol summary an...
Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial
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- Nichol, Alistair (author)
- Monash University,St Vincent's University Hospital,Alfred Hospital
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- Bellomo, Rinaldo (author)
- Monash University,Austin Hospital
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- Ady, Bridget (author)
- Monash University
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- Nielsen, Niklas (author)
- Lund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Kliniska Vetenskaper, Helsingborg,Institutionen för kliniska vetenskaper, Lund,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Clinical Sciences, Helsingborg,Department of Clinical Sciences, Lund,Center for cardiac arrest,Lund University Research Groups,Helsingborg Hospital
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- Hodgson, Carol (author)
- Monash University
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- Parke, Rachael (author)
- Auckland City Hospital
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- McGuinness, Shay (author)
- Auckland City Hospital
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- Skrifvars, Markus (author)
- University of Helsinki
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- Stub, Dion (author)
- Monash University,Alfred Health
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- Bernard, Stephen (author)
- Monash University
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- Taccone, Fabio (author)
- Université Libre de Bruxelles (ULB)
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- Archer, John (author)
- University of Melbourne
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- Neto, Ary Serpa (author)
- Monash University
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- Trapani, Tony (author)
- Monash University
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- Ainscough, Kate (author)
- St Vincent's University Hospital
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- Hunt, Anna (author)
- Medical Research Institute of New Zealand
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- Kutsogiannis, Jim (author)
- Royal Alexandra Hospital
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- Eastwood, Glenn M. (author)
- Monash University,Austin Hospital
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(creator_code:org_t)
- 2021
- 2021
- English 12 s.
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In: Critical Care and Resuscitation. - 1441-2772. ; 23:4, s. 374-385
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Abstract
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- Background: Targeted therapeutic mild hypercapnia may attenuate brain injury in comatose adults resuscitated from out-of-hospital cardiac arrest. Objective: To describe the study protocol and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial. Design, setting, participants and interventions: TAME is a phase 3, multicentre, parallel-group, participant-and outcome assessor-blinded randomised controlled trial that will be conducted in intensive care units in Australia, Canada, Ireland, Saudi Arabia, New Zealand, Scandinavia, Singapore, Central and Western Europe, and the United Kingdom. A total of 1700 comatose adults resuscitated from out-of-hospital cardiac arrest will be randomly assigned to 24 hours of targeted therapeutic mild hypercapnia (arterial carbon dioxide tension 50–55 mmHg) or targeted normocapnia (arterial carbon dioxide tension 35–45 mmHg) in a 1:1 ratio. TAME recruitment began in March 2018 and is expected to be complete in September 2021. Main outcome measures: The primary outcome measure is the proportion of participants with a favourable functional outcome at 6 months. Functional outcomes will be assessed using the Glasgow Outcome Scale-Extended (GOSE); this scale ranges from 1 to 8, with a higher value indicating a better outcome. We will define participants with a GOSE of 5 to 8 as having a favourable functional outcome. Secondary outcomes include 6-month mortality, cognitive function and quality of life. All analyses will be conducted on an intention-to-treat basis. Results and conclusions: TAME will compare the effect of targeted therapeutic mild hypercapnia versus targeted normocapnia on functional outcomes in adults resuscitated from out-of-hospital cardiac arrest who are admitted to an intensive care unit. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12617000036314p) and ClinicalTrials.gov (NCT03114033).
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Anestesi och intensivvård (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Anesthesiology and Intensive Care (hsv//eng)
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- ref (subject category)
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- By the author/editor
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Nichol, Alistair
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Bellomo, Rinaldo
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Ady, Bridget
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Nielsen, Niklas
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Hodgson, Carol
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Parke, Rachael
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show more...
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McGuinness, Shay
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Skrifvars, Marku ...
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Stub, Dion
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Bernard, Stephen
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Taccone, Fabio
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Archer, John
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Neto, Ary Serpa
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Trapani, Tony
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Ainscough, Kate
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Hunt, Anna
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Kutsogiannis, Ji ...
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Eastwood, Glenn ...
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show less...
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Critical Care an ...
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Lund University