Prolonged Mild Therapeutic Hypothermia versus Fever Control with Tight Hemodynamic Monitoring and Slow Rewarming in Patients with Severe Traumatic Brain Injury: A Randomized Controlled Trial
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- 1 April 2015
- journal article
- research article
- Published by Mary Ann Liebert Inc in Journal of Neurotrauma
- Vol. 32 (7), 422-429
- https://doi.org/10.1089/neu.2013.3197
Abstract
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).Keywords
This publication has 29 references indexed in Scilit:
- Targeted Temperature Management at 33°C versus 36°C after Cardiac ArrestThe New England Journal of Medicine, 2013
- Moderate Hypothermia to Treat Perinatal Asphyxial EncephalopathyThe New England Journal of Medicine, 2009
- Whole-Body Hypothermia for Neonates with Hypoxic–Ischemic EncephalopathyThe New England Journal of Medicine, 2005
- Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trialThe Lancet, 2005
- Moderate hypothermia in neonatal encephalopathy: Efficacy outcomesPediatric Neurology, 2005
- Mild Therapeutic Hypothermia to Improve the Neurologic Outcome after Cardiac ArrestThe New England Journal of Medicine, 2002
- Treatment of Comatose Survivors of Out-of-Hospital Cardiac Arrest with Induced HypothermiaThe New England Journal of Medicine, 2002
- Moderate hypothermia improves imbalances of thromboxane A2 and prostaglandin I2 production after traumatic brain injury in humansCritical Care Medicine, 2000
- Treatment of Traumatic Brain Injury with Moderate HypothermiaThe New England Journal of Medicine, 1997
- A Phase II Study of Moderate Hypothermia in Severe Brain InjuryJournal of Neurotrauma, 1993