Out-Of-Hospital Cardiac ArrestTAMENCT03114033
Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest
A study testing Targeted therapeutic mild hypercapnia in people with Out-Of-Hospital Cardiac Arrest, run by Australian and New Zealand Intensive Care Research Centre at 52 sites in 14 countries.
Trial summary
The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Targeted therapeutic mild hypercapnia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 52 sitesin 14 countries
- Study dates
- 15 Feb 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age ≥18 years or older)
- Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause
- Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
- Unconscious (FOUR-score motor response of <4, not able to obey verbal commands after sustained ROSC) (Appendix D)
- Eligible for intensive care without restrictions or limitations
- Within <180 minutes of ROSC
Who cannot join
- Unwitnessed cardiac arrest with an initial rhythm of asystole
- Temperature on admission <30oC
- On ECMO prior to ROSC
- Obvious or suspected pregnancy
- Intracranial bleeding
- Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy
Trial locations and contacts
52 sites in 14 countries.
52 sites in 14 countries
Australia20 sites
Flinders Medical Centre
Adelaide, South Australia, 3929
Ballarat Base Hospital
Ballarat, Victoria, 3350
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Prince Charles Hospital
Chermside, Queensland, 4032
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
The Northern Hospital
Epping, Victoria, 3076
University Hospital Geelong
Geelong, Victoria
Alfred Health
Melbourne, Victoria, 3004
Footscray Hospital-Western Health
Melbourne, Victoria, 3011
Sunshine Hospital-Western Health
Melbourne, Victoria, 3021
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Austin Health
Melbourne, Victoria, 3084
Nepean Hospital
Penrith, New South Wales, 2750
Gold Coast University Hospital
Southport, Queensland, 4215
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Nambour Hospital
Sunshine Coast, Queensland, 4560
Sunshine Coast University Hospital
Sunshine Coast, Queensland, 4575
Royal Darwin Hospital
Tiwi, Northern Territory, 0810
Wollongong Hospital
Wollongong, New South Wales, 2500
United Kingdom8 sites
Royal Victoria Hospital Belfast
Belfast, BT12 6BA
Birmingham University Hospital
Birmingham, B15 2TH
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Bristol Royal Infirmary
Bristol, BS2 8HW
University Hospital Wales
Cardiff, CF14 4XW
Queen Alexandra Hospital Portsmouth
Cosham, Portsmouth, PO6 3LY
Manchester Royal Infirmary
Manchester, M13 9WL
Royal Berkshire Hospital
Reading, RG1 5AN
New Zealand7 sites
North Shore Hospital
Auckland, 0622
Auckland City Hospital CVICU
Grafton, Auckland, 1023
Auckland City Hospital DCCM
Grafton, Auckland, 1023
Wellington Regional Hospital
Newtown, Wellington Region, 6021
Middlemore Hospital
Otahuhu, Auckland, 2025
Christchurch Hospital
Riccarton, Christchurch, 8011
Rotorua Hospital
Rotorua, 3010
Ireland4 sites
St. Vincent's University Hospital
Dublin, Dublin 4
St. James's Hospital
Dublin, Dublin 8
Beaumont Hospital
Dublin, Dublin 9
University Hospital Galway
Galway, H91 YR71
Belgium3 sites
Cliniques Universitaires de Bruxelles Hospital Erasme
Brussels, 1070
Ziekenhuis Oost-Limburg AV
Genk, 3600
University Hospital Ghent
Ghent, 9000
Sweden2 sites
Skane Region-Helsingborg
Helsingborg, 25437
Skane Region Malmö
Malmö, 21421
About this study
Official title: TAME Cardiac Arrest Trial: Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial
The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.
Read the detailed description
Cardiac arrest is a common and catastrophic event with substantial human and financial costs. It is well understood that cardiac arrest leads to brain injury. However, what is not widely appreciated is that, after circulation has been restored, cerebral hypoperfusion continues. Ongoing cerebral vasoconstriction and cerebral hypoxia has been demonstrated using technologies that include positron emission tomography, ultrasound, jugular bulb oxygen saturation and cerebral oximetry.
A likely mechanism responsible for sustained early cerebral hypoperfusion relates to impaired cerebrovascular auto-regulation. Such impaired cerebral auto-regulation may make even a normal arterial carbon dioxide tension (PaCO2) (the major physiological regulator of cerebral blood flow) insufficient to achieve and maintain adequate cerebral perfusion and, consequently, cerebral oxygenation. However, PaCO2 is the major determinant of cerebral blood flow and an increased PaCO2 (hypercapnia) markedly increases cerebral blood flow. Moreover, arterial carbon dioxide is modifiable and, as such, is a potential therapeutic target.
The TAME Cardiac Arrest Trial is a definitive phase III multi-centre randomised controlled trial in resuscitated cardiac arrest patients. This trial will determine whether targeted therapeutic mild hypercapnia (TTMH) applied during the first 24 hours of mechanical ventilation in the intensive care unit (ICU) improves neurological outcome at 6 months compared to standard care (targeted normocapnia (TN).
Supported by compelling preliminary data, significant improvements in patient outcomes are achievable with this proposed simple and cost free therapy. Recruiting 1,700 patients, for multiple sites in many countries, this will be the largest trial ever conducted involving resuscitated cardiac arrest patients admitted to the ICU. If the TAME Cardiac Arrest Trial confirms that TTMH is effective, its findings will improve the lives of many, transform clinical practice and yield major economic gains worldwide.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Targeted therapeutic mild hypercapnia, Targeted normocapnia (Standard care)
- Keywords
- Cardiac Arrest, Intensive Care Unit, Therapeutic Mild Hypercapnia, Normocapnia, Mortality, Neurological function
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted therapeutic mild hypercapniaOther
Patients allocated to the TTMH protocol will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of -4). Arterial blood gases and end- tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 50-55 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change >5 mmHg
Targeted normocapnia (Standard care)Other
Patients allocated to the standard care (TN) protocol will be managed according to current practice and in accordance with ILCOR guidelines which recommend maintaining normocapnia in these patients. They will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of - 4). Arterial blood gases and end-tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 35-45 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change >5 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Targeted therapeutic mild hypercapnia | Experimental | Target arterial carbon dioxide range of 50-55 mmHg for 24 hours following randomisation Receives: Other: Targeted therapeutic mild hypercapnia |
| Targeted normocapnia (Standard care) | Active comparator | Target arterial carbon dioxide range of 35-45 mmHg for 24 hours following randomisation Receives: Other: Targeted normocapnia (Standard care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome
Proportion of patients with a favourable (score ≥5) neurological outcome as assessed using the Glasgow Outcomes Score Extended (GOSE) method.
Measured: 6 months following enrolment
Secondary outcomes (8)
Mortality at intensive care unit discharge
Mortality at intensive care unit discharge
Measured: 6 months after randomisation
Mortality at hospital discharge
Mortality at hospital discharge
Measured: 6 months after randomisation
Health-related Quality of Life (EQ-5D-5L)
Health-related Quality of Life (EQ-5D-5L) at 6 months
Measured: 6 months after randomisation
modified Rankin scale (mRS)
modified Rankin scale (mRS) with favourable score of equal to or less than 3
Measured: 6 months after randomisation
Montreal Cognitive Assessment (MoCA-blind)
Montreal Cognitive Assessment (MoCA-blind) at 6 months
Measured: 6 months after randomisation
Mortality at 6 months
Mortality at 6 months
Measured: 6 months after randomisation
Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest (IQCODE)
IQCODE
Measured: 6 months after randomisation
Symbol Digit Modality Test
SDMT at 6 months
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Feb 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Health Research Board, Ireland
- Responsible party
- Sponsor
- Investigators
- Glenn M Eastwood, RN, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114033
- Sponsor's protocol ID
- ANZIC-RC/SB001
- Acronym
- TAME
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eastwood GM, Schneider AG, Suzuki S, Peck L, Young H, Tanaka A, Martensson J, Warrillow S, McGuinness S, Parke R, Gilder E, Mccarthy L, Galt P, Taori G, Eliott S, Lamac T, Bailey M, Harley N, Barge D, Hodgson CL, Morganti-Kossmann MC, Pebay A, Conquest A, Archer JS, Bernard S, Stub D, Hart GK, Bellomo R. Targeted therapeutic mild hypercapnia after cardiac arrest: A phase II multi-centre randomised controlled trial (the CCC trial). Resuscitation. 2016 Jul;104:83-90. doi: 10.1016/j.resuscitation.2016.03.023. Epub 2016 Apr 7.
PubMed 27060535Melberg MB, Rootwelt SD, Flaa A, Andersen GO, Sunde K, Eastwood G, Bellomo R, Olasveengen TM, Qvigstad E. The Effects of Targeted Mild Hypercapnia on Right Ventricular Function After Out-of-Hospital Cardiac Arrest: A Substudy of the Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest Trial. Chest. 2026 Jul;170(1):105-117. doi: 10.1016/j.chest.2025.11.017. Epub 2025 Nov 24.
PubMed 41297587Lee YY, Eastwood G, Bailey MJ, Bellomo R, Nichol AD, Parke RL, McGuinness S, Bernard S, Arabi YM, Capellier G, Chia YW, Grejs A, Haenggi M, Kutsogiannis D, Landoni G, Markota A, Nielsen N, Olasveengen T, Skrifvars MB, Taccone F, Wise MP, Higgins AM; TAME Study Investigators. The cost-effectiveness of mild hypercapnia after out-of-hospital cardiac arrest: a health economic evaluation alongside the TAME study. Resuscitation. 2025 Dec;217:110878. doi: 10.1016/j.resuscitation.2025.110878. Epub 2025 Oct 30.
PubMed 41176021Melberg MB, Flaa A, Andersen GO, Sunde K, Bellomo R, Eastwood G, Olasveengen TM, Qvigstad E. Effects of mild hypercapnia on myocardial injury after out-of-hospital cardiac arrest. A sub-study of the TAME trial. Resuscitation. 2024 Aug;201:110295. doi: 10.1016/j.resuscitation.2024.110295. Epub 2024 Jun 25.
PubMed 38936652Nichol A, Bellomo R, Ady B, Nielsen N, Hodgson C, Parke R, McGuinness S, Skrifvars M, Stub D, Bernard S, Taccone F, Archer J, Neto AS, Trapani T, Ainscough K, Hunt A, Kutsogiannis J, Eastwood GM. Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial. Crit Care Resusc. 2023 Oct 18;23(4):374-385. doi: 10.51893/2021.4.OA2. eCollection 2021 Dec 6.
PubMed 38046686Eastwood G, Nichol AD, Hodgson C, Parke RL, McGuinness S, Nielsen N, Bernard S, Skrifvars MB, Stub D, Taccone FS, Archer J, Kutsogiannis D, Dankiewicz J, Lilja G, Cronberg T, Kirkegaard H, Capellier G, Landoni G, Horn J, Olasveengen T, Arabi Y, Chia YW, Markota A, Haenggi M, Wise MP, Grejs AM, Christensen S, Munk-Andersen H, Granfeldt A, Andersen GO, Qvigstad E, Flaa A, Thomas M, Sweet K, Bewley J, Backlund M, Tiainen M, Iten M, Levis A, Peck L, Walsham J, Deane A, Ghosh A, Annoni F, Chen Y, Knight D, Lesona E, Tlayjeh H, Svensek F, McGuigan PJ, Cole J, Pogson D, Hilty MP, During JP, Bailey MJ, Paul E, Ady B, Ainscough K, Hunt A, Monahan S, Trapani T, Fahey C, Bellomo R; TAME Study Investigators. Mild Hypercapnia or Normocapnia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2023 Jul 6;389(1):45-57. doi: 10.1056/NEJMoa2214552. Epub 2023 Jun 15.
PubMed 37318140
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAME Cardiac Arrest Trial: Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03114033
- Acronym / sponsor ID
- TAME / ANZIC-RC/SB001
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Cardiac Arrest, Intensive Care Unit, Therapeutic Mild Hypercapnia, Normocapnia, Mortality, Neurological function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Health Research Board, Ireland
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.
Detailed description
Cardiac arrest is a common and catastrophic event with substantial human and financial costs. It is well understood that cardiac arrest leads to brain injury. However, what is not widely appreciated is that, after circulation has been restored, cerebral hypoperfusion continues. Ongoing cerebral vasoconstriction and cerebral hypoxia has been demonstrated using technologies that include positron emission tomography, ultrasound, jugular bulb oxygen saturation and cerebral oximetry.
A likely mechanism responsible for sustained early cerebral hypoperfusion relates to impaired cerebrovascular auto-regulation. Such impaired cerebral auto-regulation may make even a normal arterial carbon dioxide tension (PaCO2) (the major physiological regulator of cerebral blood flow) insufficient to achieve and maintain adequate cerebral perfusion and, consequently, cerebral oxygenation. However, PaCO2 is the major determinant of cerebral blood flow and an increased PaCO2 (hypercapnia) markedly increases cerebral blood flow. Moreover, arterial carbon dioxide is modifiable and, as such, is a potential therapeutic target.
The TAME Cardiac Arrest Trial is a definitive phase III multi-centre randomised controlled trial in resuscitated cardiac arrest patients. This trial will determine whether targeted therapeutic mild hypercapnia (TTMH) applied during the first 24 hours of mechanical ventilation in the intensive care unit (ICU) improves neurological outcome at 6 months compared to standard care (targeted normocapnia (TN).
Supported by compelling preliminary data, significant improvements in patient outcomes are achievable with this proposed simple and cost free therapy. Recruiting 1,700 patients, for multiple sites in many countries, this will be the largest trial ever conducted involving resuscitated cardiac arrest patients admitted to the ICU. If the TAME Cardiac Arrest Trial confirms that TTMH is effective, its findings will improve the lives of many, transform clinical practice and yield major economic gains worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Targeted therapeutic mild hypercapnia | Experimental | Other: Targeted therapeutic mild hypercapniaTarget arterial carbon dioxide range of 50-55 mmHg for 24 hours following randomisation |
| Targeted normocapnia (Standard care) | Active comparator | Other: Targeted normocapnia (Standard care)Target arterial carbon dioxide range of 35-45 mmHg for 24 hours following randomisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (age ≥18 years or older)
- Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause
- Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
- Unconscious (FOUR-score motor response of <4, not able to obey verbal commands after sustained ROSC) (Appendix D)
- Eligible for intensive care without restrictions or limitations
Key exclusion criteria (6 listed)
- Unwitnessed cardiac arrest with an initial rhythm of asystole
- Temperature on admission <30oC
- On ECMO prior to ROSC
- Obvious or suspected pregnancy
- Intracranial bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted therapeutic mild hypercapniaPatients allocated to the TTMH protocol will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of -4). Arterial blood gases and end- tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 50-55 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change >5 mmHg | Other | Targeted therapeutic mild hypercapnia |
| Targeted normocapnia (Standard care)Patients allocated to the standard care (TN) protocol will be managed according to current practice and in accordance with ILCOR guidelines which recommend maintaining normocapnia in these patients. They will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of - 4). Arterial blood gases and end-tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 35-45 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change >5 mmHg. | Other | Targeted normocapnia (Standard care) |
Primary outcome
Neurological outcome
Time frame: 6 months following enrolment
Proportion of patients with a favourable (score ≥5) neurological outcome as assessed using the Glasgow Outcomes Score Extended (GOSE) method.
8 secondary outcomes
Mortality at intensive care unit discharge
Time frame: 6 months after randomisation
Mortality at hospital discharge
Time frame: 6 months after randomisation
Health-related Quality of Life (EQ-5D-5L)
Time frame: 6 months after randomisation
modified Rankin scale (mRS)
Time frame: 6 months after randomisation
Montreal Cognitive Assessment (MoCA-blind)
Time frame: 6 months after randomisation
Mortality at 6 months
Time frame: 6 months after randomisation
Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest (IQCODE)
Time frame: 6 months after randomisation
Symbol Digit Modality Test
Time frame: 6 months after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Results publication: PubMed 27060535Eastwood GM, Schneider AG, Suzuki S, Peck L, Young H, Tanaka A, Martensson J, Warrillow S, McGuinness S, Parke R, Gilder E, Mccarthy L, Galt P, Taori G, Eliott S, Lamac T, Bailey M, Harley N, Barge D, Hodgson CL, Morganti-Kossmann MC, Pebay A, Conquest A, Archer JS, Bernard S, Stub D, Hart GK, Bellomo R. Targeted therapeutic mild hypercapnia after cardiac arrest: A phase II multi-centre randomised controlled trial (the CCC trial). Resuscitation. 2016 Jul;104:83-90. doi: 10.1016/j.resuscitation.2016.03.023. Epub 2016 Apr 7.
- Derived from this study: PubMed 41297587Melberg MB, Rootwelt SD, Flaa A, Andersen GO, Sunde K, Eastwood G, Bellomo R, Olasveengen TM, Qvigstad E. The Effects of Targeted Mild Hypercapnia on Right Ventricular Function After Out-of-Hospital Cardiac Arrest: A Substudy of the Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest Trial. Chest. 2026 Jul;170(1):105-117. doi: 10.1016/j.chest.2025.11.017. Epub 2025 Nov 24.
- Derived from this study: PubMed 41176021Lee YY, Eastwood G, Bailey MJ, Bellomo R, Nichol AD, Parke RL, McGuinness S, Bernard S, Arabi YM, Capellier G, Chia YW, Grejs A, Haenggi M, Kutsogiannis D, Landoni G, Markota A, Nielsen N, Olasveengen T, Skrifvars MB, Taccone F, Wise MP, Higgins AM; TAME Study Investigators. The cost-effectiveness of mild hypercapnia after out-of-hospital cardiac arrest: a health economic evaluation alongside the TAME study. Resuscitation. 2025 Dec;217:110878. doi: 10.1016/j.resuscitation.2025.110878. Epub 2025 Oct 30.
- Derived from this study: PubMed 38936652Melberg MB, Flaa A, Andersen GO, Sunde K, Bellomo R, Eastwood G, Olasveengen TM, Qvigstad E. Effects of mild hypercapnia on myocardial injury after out-of-hospital cardiac arrest. A sub-study of the TAME trial. Resuscitation. 2024 Aug;201:110295. doi: 10.1016/j.resuscitation.2024.110295. Epub 2024 Jun 25.
- Derived from this study: PubMed 38046686Nichol A, Bellomo R, Ady B, Nielsen N, Hodgson C, Parke R, McGuinness S, Skrifvars M, Stub D, Bernard S, Taccone F, Archer J, Neto AS, Trapani T, Ainscough K, Hunt A, Kutsogiannis J, Eastwood GM. Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial. Crit Care Resusc. 2023 Oct 18;23(4):374-385. doi: 10.51893/2021.4.OA2. eCollection 2021 Dec 6.
- Derived from this study: PubMed 37318140Eastwood G, Nichol AD, Hodgson C, Parke RL, McGuinness S, Nielsen N, Bernard S, Skrifvars MB, Stub D, Taccone FS, Archer J, Kutsogiannis D, Dankiewicz J, Lilja G, Cronberg T, Kirkegaard H, Capellier G, Landoni G, Horn J, Olasveengen T, Arabi Y, Chia YW, Markota A, Haenggi M, Wise MP, Grejs AM, Christensen S, Munk-Andersen H, Granfeldt A, Andersen GO, Qvigstad E, Flaa A, Thomas M, Sweet K, Bewley J, Backlund M, Tiainen M, Iten M, Levis A, Peck L, Walsham J, Deane A, Ghosh A, Annoni F, Chen Y, Knight D, Lesona E, Tlayjeh H, Svensek F, McGuigan PJ, Cole J, Pogson D, Hilty MP, During JP, Bailey MJ, Paul E, Ady B, Ainscough K, Hunt A, Monahan S, Trapani T, Fahey C, Bellomo R; TAME Study Investigators. Mild Hypercapnia or Normocapnia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2023 Jul 6;389(1):45-57. doi: 10.1056/NEJMoa2214552. Epub 2023 Jun 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn M Eastwood, RN, PhD principal investigator
Monash University
52 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted therapeutic mild hypercapnia in people with Out-Of-Hospital Cardiac Arrest, run by Australian and New Zealand Intensive Care Research Centre at 52 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Australia, United Kingdom, New Zealand, Ireland, Belgium and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcome (time frame: 6 months following enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114033, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.