TY - JOUR
T1 - Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial
AU - Nichol, Alistair
AU - Bellomo, Rinaldo
AU - Ady, Bridget
AU - Nielsen, Niklas
AU - Hodgson, Carol
AU - Parke, Rachael
AU - McGuinness, Shay
AU - Skrifvars, Markus
AU - Stub, Dion
AU - Bernard, Stephen
AU - Taccone, Fabio
AU - Archer, John
AU - Neto, Ary Serpa
AU - Trapani, Tony
AU - Ainscough, Kate
AU - Hunt, Anna
AU - Kutsogiannis, Jim
AU - Eastwood, Glenn M.
AU - for the TAME study and the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG), the Irish Critical Care Clinical Trials Network (ICC-CTN), and the Australian Resuscitation Outcomes Consortium (Aus-ROC)
N1 - Funding Information:
Acknowledgements: The TAME trial is funded by grants from the National Health and Medical Research Council (Australia; APP1119855), the Health Research Board (Ireland; DIFA-2017-036), the Health Research Council of New Zealand (18/160), and an unrestricted investigator-initiated research grant from Baxter Healthcare. The funding bodies had no input into the design or conduct of the trial or into the statistical analysis plan, and they will have no input into analysis or reporting of results. The study is coordinated in Australia by the Australian and New Zealand Intensive Care Research Centre, in conjunction with the Irish Critical Care Clinical Trials Network (covering Ireland and Europe) and the Medical Research Institute of New Zealand. This study is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Irish Critical Care Clinical Trials Group and the Australian Resuscitation Outcomes Consortium.
Publisher Copyright:
© 2021, College of Intensive Care Medicine. All rights reserved.
PY - 2021/12
Y1 - 2021/12
N2 - 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).
AB - 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).
UR - http://www.scopus.com/inward/record.url?scp=85126636801&partnerID=8YFLogxK
U2 - 10.51893/2021.4.OA2
DO - 10.51893/2021.4.OA2
M3 - Article
AN - SCOPUS:85126636801
SN - 1441-2772
VL - 23
SP - 374
EP - 385
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
IS - 4
ER -