TY - JOUR
T1 - Prolonged mild therapeutic hypothermia versus fever control with tight hemodynamic monitoring and slow rewarming in patients with severe traumatic brain injury
T2 - A randomized controlled trial
AU - Brain-Hypothermia (B-HYPO) Study Group
AU - Maekawa, Tsuyoshi
AU - Yamashita, Susumu
AU - Nagao, Seigo
AU - Hayashi, Nariyuki
AU - Ohashi, Yasuo
AU - Aibiki, Mayuki
AU - Aruga, Toru
AU - Asai, Yasufumi
AU - Dohi, Kenji
AU - Eguchi, Yutaka
AU - Fujita, Motoki
AU - Fukuoka, Toshio
AU - Ikeda, Kazumi
AU - Iwashita, Tomomi
AU - Kaneda, Kotaro
AU - Kaneko, Tadashi
AU - Kato, Yoko
AU - Kawakita, Kenya
AU - Kinoshita, Kosaku
AU - Kitahara, Takao
AU - Kitazawa, Kazuo
AU - Kobata, Hitoshi
AU - Koizumi, Hiroyasu
AU - Kuroda, Yasuhiro
AU - Marukawa, Seishiro
AU - Mori, Kazuhisa
AU - Nakamura, Hiroshi
AU - Nakamura, Shunsuke
AU - Nakatsukasa, Masashi
AU - Ninomiya, Norifumi
AU - Oda, Shigeto
AU - Oda, Yasutaka
AU - Okuchi, Kazuo
AU - Saito, Ryoichi
AU - Sugie, Atsushi
AU - Suzaki, Shinichiro
AU - Suzuki, Koichiro
AU - Suzuki, Michiyasu
AU - Taira, Yasuhiko
AU - Takezawa, Jun
AU - Tomita, Hiroki
AU - Yokota, Hiroyuki
AU - Yoshimura, Shinichi
AU - Yukioka, Tetsuo
N1 - Publisher Copyright:
© Copyright 2015, Mary Ann Liebert, Inc. 2015.
PY - 2015/4/1
Y1 - 2015/4/1
N2 - Although mild therapeutic hypothermia is an effective neuroprotective strategy for cardiac arrest/resuscitated patients, and asphyxic newborns, recent randomized controlled trials (RCTs) have equally shown good neurological outcome between targeted temperature management at 33°C versus 36°C, and have not shown consistent benefits in patients with traumatic brain injury (TBI). We aimed to determine the effect of therapeutic hypothermia, while avoiding some limitations of earlier studies, which included patient selection based on Glasgow coma scale (GCS), delayed initiation of cooling, short duration of cooling, inter-center variation in patient care, and relatively rapid rewarming. We conducted a multicenter RCT in patients with severe TBI (GCS 4-8). Patients were randomly assigned (2:1 allocation ratio) to either therapeutic hypothermia (32-34°C, n=98) or fever control (35.5-37°C, n=50). Patients with therapeutic hypothermia were cooled as soon as possible for ≥72 h and rewarmed at a rate of <1°C/day. All patients received tight hemodynamic monitoring under intensive neurological care. The Glasgow Outcome Scale was assessed at 6 months by physicians who were blinded to the treatment allocation. The overall rates of poor neurological outcomes were 53% and 48% in the therapeutic hypothermia and fever control groups, respectively. There were no significant differences in the likelihood of poor neurological outcome (relative risk [RR] 1.24, 95% confidence interval [CI] 0.62-2.48, p=0.597) or mortality (RR 1.82, 95% CI 0.82-4.03, p=0.180) between the two groups. We concluded that tight hemodynamic management and slow rewarming, together with prolonged therapeutic hypothermia (32-34°C) for severe TBI, did not improve the neurological outcomes or risk of mortality compared with strict temperature control (35.5-37°C).
AB - Although mild therapeutic hypothermia is an effective neuroprotective strategy for cardiac arrest/resuscitated patients, and asphyxic newborns, recent randomized controlled trials (RCTs) have equally shown good neurological outcome between targeted temperature management at 33°C versus 36°C, and have not shown consistent benefits in patients with traumatic brain injury (TBI). We aimed to determine the effect of therapeutic hypothermia, while avoiding some limitations of earlier studies, which included patient selection based on Glasgow coma scale (GCS), delayed initiation of cooling, short duration of cooling, inter-center variation in patient care, and relatively rapid rewarming. We conducted a multicenter RCT in patients with severe TBI (GCS 4-8). Patients were randomly assigned (2:1 allocation ratio) to either therapeutic hypothermia (32-34°C, n=98) or fever control (35.5-37°C, n=50). Patients with therapeutic hypothermia were cooled as soon as possible for ≥72 h and rewarmed at a rate of <1°C/day. All patients received tight hemodynamic monitoring under intensive neurological care. The Glasgow Outcome Scale was assessed at 6 months by physicians who were blinded to the treatment allocation. The overall rates of poor neurological outcomes were 53% and 48% in the therapeutic hypothermia and fever control groups, respectively. There were no significant differences in the likelihood of poor neurological outcome (relative risk [RR] 1.24, 95% confidence interval [CI] 0.62-2.48, p=0.597) or mortality (RR 1.82, 95% CI 0.82-4.03, p=0.180) between the two groups. We concluded that tight hemodynamic management and slow rewarming, together with prolonged therapeutic hypothermia (32-34°C) for severe TBI, did not improve the neurological outcomes or risk of mortality compared with strict temperature control (35.5-37°C).
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UR - http://www.scopus.com/inward/citedby.url?scp=84961290735&partnerID=8YFLogxK
U2 - 10.1089/neu.2013.3197
DO - 10.1089/neu.2013.3197
M3 - Article
C2 - 25099730
AN - SCOPUS:84961290735
SN - 0897-7151
VL - 32
SP - 422
EP - 429
JO - Journal of Neurotrauma
JF - Journal of Neurotrauma
IS - 7
ER -