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      Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury : The POLAR Randomized Clinical Trial

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          Abstract

          After severe traumatic brain injury, induction of prophylactic hypothermia has been suggested to be neuroprotective and improve long-term neurologic outcomes.

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          Most cited references26

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          Lack of effect of induction of hypothermia after acute brain injury.

          Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies, but the results were not definitive. To study this issue, we conducted a multicenter trial comparing the effects of hypothermia with those of normothermia in patients with acute brain injury. The study subjects were 392 patients 16 to 65 years of age with coma after sustaining closed head injuries who were randomly assigned to be treated with hypothermia (body temperature, 33 degrees C), which was initiated within 6 hours after injury and maintained for 48 hours by means of surface cooling, or normothermia. All patients otherwise received standard treatment. The primary outcome measure was functional status six months after the injury. The mean age of the patients and the type and severity of injury in the two treatment groups were similar. The mean (+/-SD) time from injury to randomization was 4.3+/-1.1 hours in the hypothermia group and 4.1+/-1.2 hours in the normothermia group, and the mean time from injury to the achievement of the target temperature of 33 degrees C in the hypothermia group was 8.4+/-3.0 hours. The outcome was poor (defined as severe disability, a vegetative state, or death) in 57 percent of the patients in both groups. Mortality was 28 percent in the hypothermia group and 27 percent in the normothermia group (P=0.79). The patients in the hypothermia group had more hospital days with complications than the patients in the normothermia group. Fewer patients in the hypothermia group had high intracranial pressure than in the normothermia group. Treatment with hypothermia, with the body temperature reaching 33 degrees C within eight hours after injury, is not effective in improving outcomes in patients with severe brain injury.
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            Hypothermia for Intracranial Hypertension after Traumatic Brain Injury.

            In patients with traumatic brain injury, hypothermia can reduce intracranial hypertension. The benefit of hypothermia on functional outcome is unclear.
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              Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial.

              The inconsistent effect of hypothermia treatment on severe brain injury in previous trials might be because hypothermia was induced too late after injury. We aimed to assess whether very early induction of hypothermia improves outcome in patients with severe brain injury. The National Acute Brain Injury Study: Hypothermia II (NABIS: H II) was a randomised, multicentre clinical trial of patients with severe brain injury who were enrolled within 2·5 h of injury at six sites in the USA and Canada. Patients with non-penetrating brain injury who were 16-45 years old and were not responsive to instructions were randomly assigned (1:1) by a random number generator to hypothermia or normothermia. Patients randomly assigned to hypothermia were cooled to 35°C until their trauma assessment was completed. Patients who had none of a second set of exclusion criteria were either cooled to 33°C for 48 h and then gradually rewarmed or treated at normothermia, depending upon their initial treatment assignment. Investigators who assessed the outcome measures were masked to treatment allocation. The primary outcome was the Glasgow outcome scale score at 6 months. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, NCT00178711. Enrolment occurred from December, 2005, to June, 2009, when the trial was terminated for futility. Follow-up was from June, 2006, to December, 2009. 232 patients were initially randomised a mean of 1·6 h (SD 0·5) after injury: 119 to hypothermia and 113 to normothermia. 97 patients (52 in the hypothermia group and 45 in the normothermia group) did not meet any of the second set of exclusion criteria. The mean time to 35°C for the 52 patients in the hypothermia group was 2·6 h (SD 1·2) and to 33°C was 4·4 h (1·5). Outcome was poor (severe disability, vegetative state, or death) in 31 of 52 patients in the hypothermia group and 25 of 56 in the normothermia group (relative risk [RR] 1·08, 95% CI 0·76-1·53; p=0·67). 12 patients in the hypothermia group died compared with eight in the normothermia group (RR 1·30, 95% CI 0·58-2·52; p=0·52). This trial did not confirm the utility of hypothermia as a primary neuroprotective strategy in patients with severe traumatic brain injury. Copyright © 2011 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                JAMA
                JAMA
                American Medical Association (AMA)
                0098-7484
                December 04 2018
                December 04 2018
                : 320
                : 21
                : 2211
                Affiliations
                [1 ]Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia
                [2 ]Departments of Intensive Care, Alfred Hospital, Melbourne, Victoria, Australia
                [3 ]Irish Critical Care Clinical Trials Network, University College Dublin-Clinical Research Centre at St Vincent’s University Hospital, Dublin, Ireland
                [4 ]Department of Anaesthesia and Intensive Care Medicine, St Vincent's University Hospital, Dublin, Ireland
                [5 ]School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland
                [6 ]Ambulance Victoria, Melbourne, Victoria, Australia
                [7 ]School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
                [8 ]Centre of Excellence in Traumatic Brain Injury Research, Monash University, Melbourne, Victoria, Australia
                [9 ]Emergency Medicine, Hamad Medical Corporation, Dhueta, Qatar
                [10 ]Emergency and Trauma Centre, Alfred Hospital, Melbourne, Victoria, Australia
                [11 ]Service de Réanimation Chirurgicale, Pôle d'Anesthésie et Réanimation Chirurgicale, Centre Hospitalier Universitaire de Besancon, Besançon, France
                [12 ]Department of Anaesthesia and Intensive Care Medicine, Hôpital de La Cavale Blanche, CHRU de Brest, Brest, France
                [13 ]UFR de médecine et des sciences de la santé, Université de Bretagne Occidenta, Brest, France
                [14 ]Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand
                [15 ]Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Victoria, Australia
                [16 ]Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
                [17 ]Queensland Ambulance Service, Brisbane, Queensland, Australia
                [18 ]Neurosurgery, Alfred Hospital, Melbourne, Victoria, Australia
                [19 ]Department of Surgery, Monash University, Melbourne, Victoria, Australia
                [20 ]Department of Surgery, F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland
                [21 ]Radiology, Alfred Hospital, Melbourne, Victoria, Australia
                [22 ]Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia
                Article
                10.1001/jama.2018.17075
                6583488
                30357266
                ac326f49-69c1-4992-8f53-85dce0c0a051
                © 2018
                History

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