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 - 2015/6/1
Y1 - 2015/6/1
N2 - 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 functionwas 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 scorewas 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 scorewas 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 survivorswas 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 scorewas 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 scorewas 49.1 (12.5) vs 49.0 (12.2) (P =.79), and the mean (SD) physical component summary scorewas 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.
AB - 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 functionwas 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 scorewas 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 scorewas 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 survivorswas 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 scorewas 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 scorewas 49.1 (12.5) vs 49.0 (12.2) (P =.79), and the mean (SD) physical component summary scorewas 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.
KW - Aged
KW - Body Temperature
KW - Cognition Disorders
KW - Female
KW - Humans
KW - Hypothermia, Induced
KW - Male
KW - Middle Aged
KW - Out-of-Hospital Cardiac Arrest
KW - Outcome Assessment (Health Care)
KW - Quality of Life
KW - Single-Blind Method
U2 - 10.1001/jamaneurol.2015.0169
DO - 10.1001/jamaneurol.2015.0169
M3 - Journal article
C2 - 25844993
SN - 2168-6149
VL - 72
SP - 634
EP - 641
JO - JAMA Neurology
JF - JAMA Neurology
IS - 6
ER -