• JAMA neurology · Jun 2015

    Randomized Controlled Trial Multicenter Study Comparative Study

    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: A Randomized Clinical Trial.

    • Tobias Cronberg, Gisela Lilja, Janneke Horn, Jesper Kjaergaard, Matt P Wise, Tommaso Pellis, Jan Hovdenes, Yvan Gasche, Anders Åneman, Pascal Stammet, David Erlinge, Hans Friberg, Christian Hassager, Michael Kuiper, Michael Wanscher, Frank Bosch, Julius Cranshaw, Gian-Reto Kleger, Stefan Persson, Johan Undén, Andrew Walden, Per Winkel, Jørn Wetterslev, Niklas Nielsen, and TTM Trial Investigators.
    • Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden2Department of Clinical Sciences, Lund University, Lund, Sweden.
    • JAMA Neurol. 2015 Jun 1;72(6):634-41.

    ImportanceBrain injury affects neurologic function and quality of life in survivors after cardiac arrest.ObjectiveTo compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest.Design, Setting, And ParticipantsIn 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.InterventionsTargeted temperature management at 33°C vs 36°C.Main Outcomes And MeasuresCognitive 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.ResultsIn 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 RelevanceQuality 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 RegistrationClinicalTrials.gov NCT01020916.

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