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Hypothermia for ICP control does not result in improved excluded from enrollment (41%) due to lack of ICP elevation. outcomes after TBI The baseline demographic and injury severity characteristics were Andrews PJD, Sinclair HL, Rodriguez A, et al. New Eng J Med 2015 similar for the 195 HYPO and 192 CON subjects. E-pub before print This is a multi-center international randomized trial comparing Mean daily ICP was similar between the two groups (adjusted induced hypothermia and standard ICP control measures for mean difference -0.48; 95% CI -2.04 to 1.08, p=0.55). The HYPO patients suffering TBI complicated by intracranial hypertension. group had a colder temperature over the fi rst 7 days of treatment Patients were eligible for enrollment if they suffered closed TBI (adjusted mean difference -2.14; 95% CI -2.34 to 1.94, p <0.001). requiring ICP monitoring and experienced ICP >20 mm Hg for Stage 3 therapies were more common in the CON cohort (54.0 vs. 5 minutes despite standard stage 1 treatment measures (CSF 43.8%, p= not provided), though craniectomy rates were similar. drainage, sedation, ventilation control, elevated head of bed, Six-month GOS-E had an unfavorable shift for the HYPO group surgical evacuation of mass lesion, and maintenance of cerebral (adjusted odds ratio 1.53; 95% CI 1.02-2.30, p=0.04). Favorable perfusion). Enrollment was required within 10 days of injury GOS-E outcomes (5-8) were seen in 25.7% of HYPO and 36.5% and patients were required to have abnormal head CT fi ndings of CON subjects (p= 0.03). Temperature targets were achieved at and be expected to survive for at least 24 hours. Study exclusion least 80% of the time in 64.8% of HYPO (32-35°C) and 68.8% of included pre-randomization use of hypothermia or barbiturates or CON subjects (>36°C). hypothermic presentation (T <34°C). Prior studies evaluating the neuroprotective benefi ts of severe TBI Subjects underwent randomization into induced hypothermia patients have failed to demonstrate clinical effi cacy, but routinely (HYPO) or control (CON) groups, which considered balanced showed improved ICP control. This large multi-center trial failed allocation of age, medical center, GCS motor score, time from to demonstrate improved outcomes with induced hypothermia injury, and pupillary reactivity. Stage 2 ICP lowering interventions among a cohort with intracranial hypertension. It is surprising that included inotropes for CPP maintenance and hyperosmolar minimal difference in ICP control were noted between the CON therapy. The CON group had stage 2 therapies added as needed. and HYPO group. This may suggest that stage 2 therapies were The HYPO cohort had stage 2 interventions only if needed after routinely successful and that, perhaps, the severity of intracranial cooling implementation. Either group was eligible to receive stage hypertension was more modest than noted in previous studies. It 3 interventions for refractory intracranial hypertension as needed may also indicate that any clinical benefi t seen in this study would (barbiturate sedation or decompressive craniectomy). Primary have had to result from neuroprotective rather than ICP lowering study outcome was designated as blinded assessment of the properties of cooling. The intensity of treatment for stage 2 Extended Glasgow Outcome Scale (GOS-E) 6 months after injury. interventions were not tracked. Patient temperature in the CON Outcomes of death, vegetative state, and severe disability were group appears to have been well controlled. A CON arm with pooled to represent unacceptable clinical outcomes. rigidly managed fever avoidance may have limited the detection of treatment benefi t associated with hypothermia. Study protocols were created to guide cooled saline induction, shivering management, and rewarming. HYPO patients were cooled to 32-35°C for 48 hours or longer. The depth and duration of cooling were driven by ICP control. Enrollment was planned for 600 patients. Recruitment was stopped by the study steering committee after concluding that harm was possible and futility was likely. At the time of study cessation, 2,498 patients had been screened and 387 subjects enrolled. Many patients were 23


232747_NCS Currents_December_2_eMag
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