TY - JOUR

T1 - Neurologic function and health-related quality of life in patients following targeted temperature management at 33°C vs 36°C after out-of-hospital cardiac arrest

T2 - A Randomized Clinical Trial

AU - Cronberg, Tobias

AU - Lilja, Gisela

AU - Horn, Janneke

AU - Kjaergaard, Jesper

AU - Wise, Matt P

AU - Pellis, Tommaso

AU - Hovdenes, Jan

AU - Gasche, Yvan

AU - Åneman, Anders

AU - Stammet, Pascal

AU - Erlinge, David

AU - Friberg, Hans

AU - Hassager, Christian

AU - Kuiper, Michael

AU - Wanscher, Michael

AU - Bosch, Frank

AU - Cranshaw, Julius

AU - Kleger, Gian-Reto

AU - Persson, Stefan

AU - Undén, Johan

AU - Walden, Andrew

AU - Winkel, Per

AU - Wetterslev, Jørn

AU - Nielsen, Niklas

AU - TTM Trial Investigators

PY - 2015/4/6

Y1 - 2015/4/6

N2 - 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.

AB - 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.

U2 - 10.1001/jamaneurol.2015.0169

DO - 10.1001/jamaneurol.2015.0169

M3 - Journal article

VL - 72

SP - 634

EP - 641

JO - Archives of Neurology

JF - Archives of Neurology

SN - 2168-6149

IS - 6

ER -