Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/34465
Title: Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial.
Austin Authors: Nichol, Alistair;Bellomo, Rinaldo ;Ady, Bridget;Nielsen, Niklas;Hodgson, Carol;Parke, Rachael;McGuinness, Shay;Skrifvars, Markus;Stub, Dion;Bernard, Stephen;Taccone, Fabio;Archer, John S ;Neto, Ary Serpa;Trapani, Tony;Ainscough, Kate;Hunt, Anna;Kutsogiannis, Jim;Eastwood, Glenn M 
Affiliation: University College Dublin-Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.;Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;Intensive Care Unit, Alfred Hospital, Melbourne, VIC, Australia.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Intensive Care
Department of Clinical Sciences Lund, Anesthesiology and Intensive Care, Helsingborg Hospital, Lund University, Lund, Sweden.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Cardiothoracic and Vascular Intensive Care and High Dependency Unit, Auckland, City Hospital, Auckland, New Zealand.
HUS Emergency Medicine and Services, Department of Diagnostics and Therapeutics, University of Helsinki, Helsinki, Finland.
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Department of Intensive Care, Hôpital Erasme, Belgium.;Université Libre de Bruxelles (ULB) Brussels, Belgium.
Division of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
University College Dublin-Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Critical Care Medicine, Neurocritical Care, Royal Alexandra Hospital, Edmonton, Alberta, Canada.
Issue Date: 6-Dec-2021
Date: 2023
Publication information: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine 2021-12-06; 23(4)
Abstract: 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).
URI: https://ahro.austin.org.au/austinjspui/handle/1/34465
DOI: 10.51893/2021.4.OA2
ORCID: 
Journal: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
Start page: 374
End page: 385
PubMed URL: 38046686
Type: Journal Article
Appears in Collections:Journal articles

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