Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial

Alistair Nichol, Rinaldo Bellomo, Bridget Ady, Niklas Nielsen, Carol Hodgson, Rachael Parke, Shay McGuinness, Markus Skrifvars, Dion Stub, Stephen Bernard, Fabio Taccone, John Archer, Ary Serpa Neto, Tony Trapani, Kate Ainscough, Anna Hunt, Jim Kutsogiannis, Glenn M. Eastwood, 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)

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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).

Original languageEnglish
Pages (from-to)374-385
Number of pages12
JournalCritical Care and Resuscitation
Volume23
Issue number4
DOIs
Publication statusPublished - Dec 2021

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