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Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial
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 (T...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10692552/ https://www.ncbi.nlm.nih.gov/pubmed/38046686 http://dx.doi.org/10.51893/2021.4.OA2 |
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author | Nichol, Alistair Bellomo, Rinaldo Ady, Bridget Nielsen, Niklas Hodgson, Carol Parke, Rachael McGuinness, Shay Skrifvars, Markus Stub, Dion Bernard, Stephen Taccone, Fabio Archer, John Neto, Ary Serpa Trapani, Tony Ainscough, Kate Hunt, Anna Kutsogiannis, Jim Eastwood, Glenn M. |
author_facet | Nichol, Alistair Bellomo, Rinaldo Ady, Bridget Nielsen, Niklas Hodgson, Carol Parke, Rachael McGuinness, Shay Skrifvars, Markus Stub, Dion Bernard, Stephen Taccone, Fabio Archer, John Neto, Ary Serpa Trapani, Tony Ainscough, Kate Hunt, Anna Kutsogiannis, Jim Eastwood, Glenn M. |
author_sort | Nichol, Alistair |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-10692552 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-106925522023-12-03 Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial Nichol, Alistair Bellomo, Rinaldo Ady, Bridget Nielsen, Niklas Hodgson, Carol Parke, Rachael McGuinness, Shay Skrifvars, Markus Stub, Dion Bernard, Stephen Taccone, Fabio Archer, John Neto, Ary Serpa Trapani, Tony Ainscough, Kate Hunt, Anna Kutsogiannis, Jim Eastwood, Glenn M. Crit Care Resusc Original Articles 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). Elsevier 2023-10-18 /pmc/articles/PMC10692552/ /pubmed/38046686 http://dx.doi.org/10.51893/2021.4.OA2 Text en © 2021 College of Intensive Care Medicine of Australia and New Zealand. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Original Articles Nichol, Alistair Bellomo, Rinaldo Ady, Bridget Nielsen, Niklas Hodgson, Carol Parke, Rachael McGuinness, Shay Skrifvars, Markus Stub, Dion Bernard, Stephen Taccone, Fabio Archer, John Neto, Ary Serpa Trapani, Tony Ainscough, Kate Hunt, Anna Kutsogiannis, Jim Eastwood, Glenn M. Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial |
title | Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial |
title_full | Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial |
title_fullStr | Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial |
title_full_unstemmed | Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial |
title_short | Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial |
title_sort | protocol summary and statistical analysis plan for the targeted therapeutic mild hypercapnia after resuscitated cardiac arrest (tame) trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10692552/ https://www.ncbi.nlm.nih.gov/pubmed/38046686 http://dx.doi.org/10.51893/2021.4.OA2 |
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