Lack of Effect of Induction of Hypothermia after Acute Brain Injury

Clifton, Guy L.; Miller, Emmy R.; Choi, Sung C.; Levin, Harvey S.; McCauley, Stephen R.; Smith, Kenneth R.; Muizelaar, J. Paul; Wagner, Franklin C.; Marion, Donald W.; Luerssen, Thomas G.; Chesnut, Randall M.; Schwartz, Michael L.

doi:10.1056/nejm200102223440803

Cited by 1,301 publications

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“…[H2] The USA In the USA, the GOS has been used extensively in single-centre and multicentre observational studies of severe TBI, including the National Coma Data Bank and NIH-funded clinical trials 93,94 . An undisputed advantage of the GOS and GOSE for trials in severe head injury is its capability to grade outcome in patients who are noncommunicative, or when standard performance-based outcome measures are not feasible through the use of clinical observation and/or input from a collateral source such as a carer or relative.…”

Section: [H1] International Developmentsmentioning

confidence: 99%

The Glasgow Outcome Scale — 40 years of application and refinement

et al. 2016

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Section: [H1] International Developmentsmentioning

confidence: 99%

The Glasgow Outcome Scale — 40 years of application and refinement

et al. 2016

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“…Bradycardia associated with hypotension also occurred four times more frequently in this group, electrolyte disorders and hyperglycaemia were also found more frequently in the hypothermia group [9]. All of these complications are known side effects of hypothermia.…”

Section: Introductionmentioning

confidence: 93%

“…Eighteen studies, with outcome data available for 2096 patients, used hypothermia in patients with high ICP that was refractory to "conventional" treatments (usually sedation/analgesia, muscle relaxants, osmotic therapy, and sometimes barbiturates) [9-26]. The results are summarised in Figure 1.…”

Section: Introductionmentioning

confidence: 99%

“…In contrast, one of the two largest multi-centre randomised controlled trials (RCTs) failed to show that therapeutic hypothermia improved outcome at 6 months after TBI (Relative Risk (RR) of a poor outcome 1; 95% CI 0.8-1.2; p = 0.99) [9]. Significantly more of the patients admitted to hospital with hypothermia who were randomised to normothermia, and consequently re-warmed, had a poor outcome (78% n = 31).…”

Section: Introductionmentioning

confidence: 99%

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European society of intensive care medicine study of therapeutic hypothermia (32-35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial)

Andrews

Sinclair

Battison

et al. 2011

Trials

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BackgroundTraumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union.Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming. A recent meta-analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly (1°C/4 hours). Previous experience with cooling also appears to be important if complications, which may outweigh the benefits of hypothermia, are to be avoided.Methods/designThis is a pragmatic, multi-centre randomised controlled trial examining the effects of hypothermia 32-35°C, titrated to reduce intracranial pressure <20 mmHg, on morbidity and mortality 6 months after traumatic brain injury. The study aims to recruit 1800 patients over 41 months. Enrolment started in April 2010.Participants are randomised to either standard care or standard care with titrated therapeutic hypothermia. Hypothermia is initiated with 20-30 ml/kg of intravenous, refrigerated 0.9% saline and maintained using each centre's usual cooling technique. There is a guideline for detection and treatment of shivering in the intervention group. Hypothermia is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to maintain intracranial pressure <20 mmHg. Intracranial hypertension is defined as an intracranial pressure >20 mmHg in accordance with the Brain Trauma Foundation Guidelines, 2007.DiscussionThe Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine, because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial randomised controlled trial due to the substantial number of centres required to deliver the target number of patients. It represents a new and fundamental step for intensive care medicine in Europe. Recruitment will continue until January 2013 and interested clinicians from intensive care units worldwide can still join this important collaboration by contacting the Trial Coordinating Team via the trial website http://www.eurotherm3235trial.eu.Trial registrationCurrent Controlled Trials ISRCTN34555414

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“…The targeted temperature management (TTM) trial [6] showed that aiming for a body temperature of 36°C resulted in an upper limit of the 95 % confidence interval of recorded temperatures of between 37.0 and 37.5°C, meaning that this strategy resulted in strict avoidance of fever, which was not inferior to mild hypothermia (33°C) in comatose patients after cardiac arrest. The results have pointed out that previous hypothermia trials may have actually compared hypothermia versus a strategy allowing for the occurrence of fever, which is not the same as strict normothermia [7,8]. This insight was one of the reasons to perform the TTM trial: was the beneficial effect of mild hypothermia caused by the avoidance of fever rather than the hypothermia itself?…”

mentioning

confidence: 99%