Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT03114033
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-15', 'releaseDate': '2023-09-05'}, {'resetDate': '2024-08-14', 'releaseDate': '2024-03-17'}], 'estimatedResultsFirstSubmitDate': '2023-09-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A Randomised, Parallel Groups, Assessor Blinded, Clinical Trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality Adjust Life Years (QALYs)', 'timeFrame': '6 months after randomisation', 'description': 'Quality Adjust Life Years (QALYs)'}, {'measure': 'Health economic evaluation', 'timeFrame': '6 months after randomisation', 'description': 'Evaluation of hospital and post-discharge estimates of costs at 6 months'}, {'measure': 'Pneumonia', 'timeFrame': 'Occurring from enrolment until Day 7 while the participant is in the intensive care unit as reported by treating clinicians.', 'description': 'Pneumonia as defined by the presence of increased or purulent trachael secretions, new or progressive radiographic infiltrate and a decreased arterial oxygen tension fraction of inspired oxygen ratio of less than 240 mmHg or less than 32 kPa'}, {'measure': 'Sepsis and septic shock', 'timeFrame': 'Occurring from enrolment until Day 7 while the participant is in the intensive care unit as reported by treating clinicians.', 'description': 'Sepsis and septic shock according to the third international consensus definitions for sepsis and septic shock as published in the journal JAMA 2016;315:801-810'}, {'measure': 'Bradycardia', 'timeFrame': 'Occurring from enrolment until Day 7 while the participant is in the intensive care unit as reported by treating clinicians.', 'description': 'Bradycardia requiring pacing'}, {'measure': 'Moderate or severe bleeding', 'timeFrame': 'Occurring from enrolment until Day 7 while the participant is in the intensive care unit as reported by treating clinicians.', 'description': 'Moderate or severe bleeding according to the GUSTO criteria as reported in the journal N Engl J Med 1993;329:673-82'}, {'measure': 'Cooling device-related skin complications', 'timeFrame': 'Occurring from enrolment until Day 7 while the participant is in the intensive care unit as reported by treating clinicians.', 'description': 'Cooling device-related skin complications as defined as being blistering or skin necrosis in areas covered by surface device.'}, {'measure': 'Arrhythmia', 'timeFrame': 'Occurring from enrolment until Day 7 while the participant is in the intensive care unit as reported by treating clinicians.', 'description': 'Arrhythmia that results in haemodynamic compromise (for example ventricular fibrillation and ventricular tachycardia).'}], 'primaryOutcomes': [{'measure': 'Neurological outcome', 'timeFrame': '6 months following enrolment', 'description': 'Proportion of patients with a favourable (score ≥5) neurological outcome as assessed using the Glasgow Outcomes Score Extended (GOSE) method.'}], 'secondaryOutcomes': [{'measure': 'Mortality at intensive care unit discharge', 'timeFrame': '6 months after randomisation', 'description': 'Mortality at intensive care unit discharge'}, {'measure': 'Mortality at hospital discharge', 'timeFrame': '6 months after randomisation', 'description': 'Mortality at hospital discharge'}, {'measure': 'Health-related Quality of Life (EQ-5D-5L)', 'timeFrame': '6 months after randomisation', 'description': 'Health-related Quality of Life (EQ-5D-5L) at 6 months'}, {'measure': 'modified Rankin scale (mRS)', 'timeFrame': '6 months after randomisation', 'description': 'modified Rankin scale (mRS) with favourable score of equal to or less than 3'}, {'measure': 'Montreal Cognitive Assessment (MoCA-blind)', 'timeFrame': '6 months after randomisation', 'description': 'Montreal Cognitive Assessment (MoCA-blind) at 6 months'}, {'measure': 'Mortality at 6 months', 'timeFrame': '6 months after randomisation', 'description': 'Mortality at 6 months'}, {'measure': 'Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest (IQCODE)', 'timeFrame': '6 months after randomisation', 'description': 'IQCODE'}, {'measure': 'Symbol Digit Modality Test', 'timeFrame': '6 months after randomisation', 'description': 'SDMT at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Arrest', 'Intensive Care Unit', 'Therapeutic Mild Hypercapnia', 'Normocapnia', 'Mortality', 'Neurological function'], 'conditions': ['Out-Of-Hospital Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '27060535', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '41297587', 'type': 'DERIVED', 'citation': 'Melberg MB, Rootwelt SD, Flaa A, Andersen GO, Sunde K, Eastwood G, Olasveengen TM, Qvigstad E. The effects of targeted mild hypercapnia on right ventricular function after out-of-hospital cardiac arrest. A sub-study of the TAME cardiac arrest trial. Chest. 2025 Nov 24:S0012-3692(25)05796-4. doi: 10.1016/j.chest.2025.11.017. Online ahead of print.'}, {'pmid': '38936652', 'type': 'DERIVED', 'citation': 'Melberg 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.'}, {'pmid': '38046686', 'type': 'DERIVED', 'citation': 'Nichol 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.'}, {'pmid': '37318140', 'type': 'DERIVED', 'citation': 'Eastwood 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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nA 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.\n\nThe 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).\n\nSupported 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age ≥18 years or older)\n* Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause\n* Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions\n* Unconscious (FOUR-score motor response of \\<4, not able to obey verbal commands after sustained ROSC) (Appendix D)\n* Eligible for intensive care without restrictions or limitations\n* Within \\<180 minutes of ROSC\n\nExclusion Criteria:\n\n* Unwitnessed cardiac arrest with an initial rhythm of asystole\n* Temperature on admission \\<30oC\n* On ECMO prior to ROSC\n* Obvious or suspected pregnancy\n* Intracranial bleeding\n* Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy'}, 'identificationModule': {'nctId': 'NCT03114033', 'acronym': 'TAME', 'briefTitle': 'Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Australian and New Zealand Intensive Care Research Centre'}, 'officialTitle': 'TAME Cardiac Arrest Trial: Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'ANZIC-RC/SB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Targeted therapeutic mild hypercapnia', 'description': 'Target arterial carbon dioxide range of 50-55 mmHg for 24 hours following randomisation', 'interventionNames': ['Other: Targeted therapeutic mild hypercapnia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Targeted normocapnia (Standard care)', 'description': 'Target arterial carbon dioxide range of 35-45 mmHg for 24 hours following randomisation', 'interventionNames': ['Other: Targeted normocapnia (Standard care)']}], 'interventions': [{'name': 'Targeted therapeutic mild hypercapnia', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Targeted therapeutic mild hypercapnia']}, {'name': 'Targeted normocapnia (Standard care)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Targeted normocapnia (Standard care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2750', 'city': 'Penrith', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Nepean Hospital', 'geoPoint': {'lat': -33.75, 'lon': 150.7}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Wollongong Hospital', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '0810', 'city': 'Tiwi', 'state': 'Northern Territory', 'country': 'Australia', 'facility': 'Royal Darwin Hospital', 'geoPoint': {'lat': -12.35876, 'lon': 130.878}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4102', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4032', 'city': 'Chermside', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Prince Charles Hospital', 'geoPoint': {'lat': -27.38472, 'lon': 153.03062}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast University Hospital', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4560', 'city': 'Sunshine Coast', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Nambour Hospital', 'geoPoint': {'lat': -26.65682, 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'country': 'New Zealand', 'facility': 'Middlemore Hospital', 'geoPoint': {'lat': -36.9382, 'lon': 174.84019}}, {'zip': '8011', 'city': 'Riccarton', 'state': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.52833, 'lon': 172.59013}}, {'zip': '6021', 'city': 'Newtown', 'state': 'Wellington Region', 'country': 'New Zealand', 'facility': 'Wellington Regional Hospital', 'geoPoint': {'lat': -41.31115, 'lon': 174.77935}}, {'zip': '0622', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'North Shore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '3010', 'city': 'Rotorua', 'country': 'New Zealand', 'facility': 'Rotorua Hospital', 'geoPoint': {'lat': -38.13874, 'lon': 176.24516}}, {'zip': '0450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital - Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '14611', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King 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{'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BS2 8HW', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Infirmary', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Royal Berkshire Hospital', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Glenn M Eastwood, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Australian and New Zealand Intensive Care Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}, {'name': 'Health Research Board, Ireland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-05', 'type': 'RELEASE'}, {'date': '2024-03-15', 'type': 'RESET'}, {'date': '2024-03-17', 'type': 'RELEASE'}, {'date': '2024-08-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Australian and New Zealand Intensive Care Research Centre'}}}}