Tobias Cronberg1, Gisela Lilja1, Janneke Horn2, Jesper Kjaergaard3, Matt P Wise4, Tommaso Pellis5, Jan Hovdenes6, Yvan Gasche7, Anders Åneman8, Pascal Stammet9, David Erlinge10, Hans Friberg11, Christian Hassager3, Michael Kuiper12, Michael Wanscher13, Frank Bosch14, Julius Cranshaw15, Gian-Reto Kleger16, Stefan Persson17, Johan Undén18, Andrew Walden19, Per Winkel20, Jørn Wetterslev20, Niklas Nielsen21. 1. Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden2Department of Clinical Sciences, Lund University, Lund, Sweden. 2. Department of Intensive Care, Academic Medical Center, Amsterdam, the Netherlands. 3. Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. 4. Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom. 5. Intensive Care Unit, Santa Maria degli Angeli, Pordenone, Italy. 6. Department of Anesthesiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway. 7. Department of Anesthesiology, Pharmacology and Intensive Care, Geneva University Hospital, Geneva, Switzerland. 8. Department of Intensive Care, Liverpool Hospital, Sydney, New South Wales, Australia. 9. Department of Anesthesiology and Intensive Care, Centre Hospitalier de Luxembourg, Luxembourg. 10. Department of Clinical Sciences, Lund University, Lund, Sweden11Department of Cardiology, Lund University, Lund, Sweden. 11. Department of Clinical Sciences, Lund University, Lund, Sweden12Department of Intensive and Perioperative Care, Skåne University Hospital, Lund, Sweden. 12. Department of Intensive Care, Academic Medical Center, Amsterdam, the Netherlands13Department of Intensive Care, Medical Center Leeuwarden, Leeuwarden, the Netherlands. 13. Department of Cardiothoracic Anesthesiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. 14. Department of Intensive Care, Rijnstaate Hospital, Arnhem, the Netherlands. 15. Department of Intensive Care, Royal Bournemouth Hospital, Bournemouth, United Kingdom. 16. Department of Intensive Care, Kantonsspital, St Gallen, Switzerland. 17. Departement of Anesthesia and Intensive Care, Örebro University Hospital, Örebro, Sweden. 18. Department of Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden. 19. Department of Intensive Care, Royal Berkshire Hospital, Reading, United Kingdom. 20. Copenhagen Trial Unit, Centre of Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. 21. Department of Clinical Sciences, Lund University, Lund, Sweden22Department of Anesthesiology and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.
Abstract
IMPORTANCE: Brain injury affects neurologic function and quality of life in survivors after cardiac arrest. OBJECTIVE: To compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter, international, parallel group, assessor-masked randomized clinical trial performed from November 11, 2010, through January 10, 2013, we enrolled 950 unconscious adults with cardiac arrest of presumed cardiac cause from 36 intensive care units in Europe and Australia. Eleven patients were excluded from analysis for a total sample size of 939. INTERVENTIONS: Targeted temperature management at 33°C vs 36°C. MAIN OUTCOMES AND MEASURES: Cognitive function was measured by the Mini-Mental State Examination (MMSE) and assessed by observers through the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Patients reported their activities in daily life and mental recovery through Two Simple Questions and their quality of life through the Medical Outcomes Study 36-Item Short Form Health Survey, version 2. RESULTS: In the modified intent-to-treat population, including nonsurvivors, the median MMSE score was 14 in the 33°C group (interquartile range [IQR], 0-28) vs 17 in the 36°C group (IQR, 0-29) (P = .77), and the IQCODE score was 115 (IQR, 79-130) vs 115 (IQR, 80-130) (P = .57) in the 33°C and 36°C groups, respectively. The median MMSE score for survivors was within the reference range and similar (33°C group median, 28; IQR, 26-30; vs 36°C group median, 28; IQR, 25-30; P = .61). The median IQCODE score was within the minor deficit range (33°C group median, 79.5; IQR, 78.0-85.9; vs 36°C group median, 80.7; IQR, 78.0-86.9; P = .04). A total of 18.8% vs 17.5% of survivors reported needing help with everyday activities (P = .71), and 66.5% in the 33°C group vs 61.8% in the 36°C group reported that they thought they had made a complete mental recovery (P = .32). The mean (SD) mental component summary score was 49.1 (12.5) vs 49.0 (12.2) (P = .79), and the mean (SD) physical component summary score was 46.8 (13.8) and 47.5 (13.8) (P = .45), comparable to the population norm. CONCLUSIONS AND RELEVANCE: Quality of life was good and similar in patients with cardiac arrest receiving targeted temperature management at 33°C or 36°C. Cognitive function was similar in both intervention groups, but many patients and observers reported impairment not detected previously by standard outcome scales. TRIAL REGISTRATION: ClinicalTrials.gov NCT01020916.
RCT Entities:
IMPORTANCE: Brain injury affects neurologic function and quality of life in survivors after cardiac arrest. OBJECTIVE: To compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter, international, parallel group, assessor-masked randomized clinical trial performed from November 11, 2010, through January 10, 2013, we enrolled 950 unconscious adults with cardiac arrest of presumed cardiac cause from 36 intensive care units in Europe and Australia. Eleven patients were excluded from analysis for a total sample size of 939. INTERVENTIONS: Targeted temperature management at 33°C vs 36°C. MAIN OUTCOMES AND MEASURES: Cognitive function was measured by the Mini-Mental State Examination (MMSE) and assessed by observers through the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Patients reported their activities in daily life and mental recovery through Two Simple Questions and their quality of life through the Medical Outcomes Study 36-Item Short Form Health Survey, version 2. RESULTS: In the modified intent-to-treat population, including nonsurvivors, the median MMSE score was 14 in the 33°C group (interquartile range [IQR], 0-28) vs 17 in the 36°C group (IQR, 0-29) (P = .77), and the IQCODE score was 115 (IQR, 79-130) vs 115 (IQR, 80-130) (P = .57) in the 33°C and 36°C groups, respectively. The median MMSE score for survivors was within the reference range and similar (33°C group median, 28; IQR, 26-30; vs 36°C group median, 28; IQR, 25-30; P = .61). The median IQCODE score was within the minor deficit range (33°C group median, 79.5; IQR, 78.0-85.9; vs 36°C group median, 80.7; IQR, 78.0-86.9; P = .04). A total of 18.8% vs 17.5% of survivors reported needing help with everyday activities (P = .71), and 66.5% in the 33°C group vs 61.8% in the 36°C group reported that they thought they had made a complete mental recovery (P = .32). The mean (SD) mental component summary score was 49.1 (12.5) vs 49.0 (12.2) (P = .79), and the mean (SD) physical component summary score was 46.8 (13.8) and 47.5 (13.8) (P = .45), comparable to the population norm. CONCLUSIONS AND RELEVANCE: Quality of life was good and similar in patients with cardiac arrest receiving targeted temperature management at 33°C or 36°C. Cognitive function was similar in both intervention groups, but many patients and observers reported impairment not detected previously by standard outcome scales. TRIAL REGISTRATION: ClinicalTrials.gov NCT01020916.
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