Type of study
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Randomized: normothermia versus hypothermia
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Randomized: normothermia versus hypothermia
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Multicentered, with nine centers in five countries
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Four accepting emergency departments
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Blinded outcome
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Not blinded for treatment or outcome
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Number of patients
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275 Total
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77 Total
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138 Normothermia
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34 Normothermia
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137 Hypothermia
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43 Hypothermia
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Criteria
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Inclusion
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Witnessed arrest
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Initial rhythm VF
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Arrest secondary to VF
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Continued coma after ROSC
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Age 18–75 years
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Age: women >50 years; men >18 years
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<60 min to ROSC
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Exclusion
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Temp <30°C
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Cardiogenic shock (SBP <90 mmHg despite epinephrine)
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Coagulopathy
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Pregnant
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Pregnant
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Awake before randomization
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Other causes of coma
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MAP <60 mmHg for >30 min
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ICU bed unavailable
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Hypoxemia for >15 min
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Terminal illness
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Unavailable for follow-up
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Enrolment in other study
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Comparability of hypothermia and normothermia groups
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The normothermia group had higher rates of coronary artery disease and diabetes mellitus
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The normothermia group had a higher percentage of bystander-performed cardiopulmonary resuscitation
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Cooling
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Temperature used
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32–34°C (bladder temperature)
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33°C
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Mechanism
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Cool air circulating device and ice packs
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Ice packs
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Time to start
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Mean 105 min
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Cooling began prehospital at a rate of 0.9°C/hour
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Duration
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24 hours
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12 hours
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Rewarming
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Passive over 8 hours
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Passive
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Side effects
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No statistical difference between the two groups
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No statistical difference between the two groups
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End-points
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Primary
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Favorable neurologic outcome at 6 months after arrest
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Discharge to home or rehabilitation
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Secondary
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(1) Mortality within 6 months
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Side effects of hemodynamic, biochemical, or hematological instability
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(2) Complications within 7 days
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Outcomes
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Hypothermia: favorable outcome in 75 patients (55%)
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Hypothermia: favorable outcome in 21 patients (49%)
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Normothermia: favorable outcome in 54 patients (39%)
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Normothermia: favorable outcome in 9 patients (26%)
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Statistical significance of the outcomes
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P = 0.009
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P = 0.046
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