This study will involve the use of therapeutic hypothermia. This prospective cohort pilot study will evaluate the clinical performance of a new device, the ThermoSuit™ System, to achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and hemodynamics in these patients. The study hypothesis is that magnesium sulfate will significantly increase the rate of cooling.
This study will involve the use of therapeutic hypothermia, an accepted medical treatment recommended for comatose post resuscitation patients by the International Liaison Committee on Resuscitation (ILCOR), the American Heart Association (AHA), and the European Resuscitation Council. This prospective cohort pilot study will evaluate the clinical performance of a new device, the ThermoSuit™ System, to achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and hemodynamics in these patients. 14 patients will be prospectively randomized to receive either magnesium sulfate or normal saline (placebo) in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Cooling with LRS ThermoSuit within 15 minutes of intravenous Magnesium Sulfate infusion (30 mg/kg, added to 100 ml normal NaCl solution, given over 15 min).
Cooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min).
Department of Emergency Medicine, Medical University of Vienna
Vienna, Austria
Cooling rate from start of cooling until a temperature of 34°C is reached
Time frame: Approximately 10 to 60 minutes after start of cooling
Time from collapse to a core temperature < 34.0°C
Time frame: Approximately 30 to 180 minutes
Percentage of time of the maintenance phase where the patient core temperature is between 32.0 and 34.0°C.
Time frame: Approximately 12 hours after initial cooling
Incidence of shivering during cooling and maintenance of hypothermia
Time frame: Approximately 12 hours after cooling
Duration of maintenance of hypothermia without supplemental cooling
Time frame: Approximately 12 hours after cooling
Total number of days in ICU
Time frame: Generally less than 30 days
Neurologic and physical status
Time frame: At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment
Adverse events, serious adverse events, device-related adverse events
Time frame: From enrollment through 6-month follow-up
Blood pressure and ECGs
Time frame: Through hospital stay
Serum chemistry parameters (standard chemistry panel)
Time frame: Through hospital stay
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Hematology parameters
Time frame: Through hospital stay
Survival
Time frame: To 24 hours, hospital discharge, and 30 days
Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis
Time frame: During hospital stay