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

Abstract

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 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. 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. 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 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.

Cognitive Function in Survivors of Out-of-Hospital Cardiac Arrest After Target Temperature Management at 33°C Versus 36°C

“…We add to the results of the main trial 5,18 that the 2 intervention groups behave similarly. Although we detected no differences between survivors allocated to 33°C or 36°C, we could confirm the results of previous smaller and less controlled studies that cognitive impairment is common among OHCA survivors.…”

“…5,17 Patients surviving to hospital discharge were invited to a face-to-face follow-up at ≈180 days after arrest to complete the neurological outcome assessments of the main trial. [16][17][18] At these follow-up visits, patients at 20 of 36 sites in 5 European countries (Sweden, Denmark, the Netherlands, Italy, and the United Kingdom) participated in this study. Matched control patients completed the same assessments as the OHCA survivors.…”

“…After the neurological tests of the main trial, 17,18 patients from the 33°C group, the 36°C group, and the STEMI control group performed cognitive tests 16 selected to assess the most commonly affected cognitive domains after OHCA: memory, attention, and executive function. 11 In addition, potential differences in psychological stress between the groups were tested.…”

“…The profile score has predefined cutoff levels to grade the memory performance as normal (22)(23)(24) mild (17)(18)(19)(20)(21), moderate (10-16), or severe (0-9) impairment. 19 The Frontal Assessment Battery 20 is a screening battery for executive impairments.…”

Post-admission outcomes of participants in the PARAMEDIC trial: A cluster randomised trial of mechanical or manual chest compressions

“…This is within the range of rates reported in other studies (range 25%-86%). [40][41][42] These high levels of missing data risk underestimating or potentially misleading the full impact of cardiac arrest amongst survivors.…”