Coma, Death, Sudden, Cardiac
Conditions
Keywords
Hypothermia, Induced, Death, Sudden, Cardiac, Resuscitation, Coma
Brief summary
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.
Detailed description
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.
Interventions
DEVICECooling with ThermoSuit with Magnesium Sulfate Infusion
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).
DEVICECooling with ThermoSuit with Normal Saline Infusion
Cooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min).
Sponsors
Medical University of Vienna
Life Recovery Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC). * Estimated or known age \> 18 years. * Intubation, ventilation and placement of esophageal temperature probe. * Persistent neurologic dysfunction i.e. comatose upon enrollment \[GCS ≤ 8\].
Exclusion criteria
* Height greater than 188 cm. * Elbow-to-elbow width greater than 60 cm (as measured above the supine patient). * Core temperature less than 35°C after ROSC (as measured in the esophagus). * Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system. * Known pregnancy. * Known terminal illness that preceded the arrest. * Known enrollment in another study of a device, drug, or biologic. * Major trauma or other co-morbidity requiring urgent surgery. * \> 4 hours since return of spontaneous circulation. * Severe coagulopathy (with active bleeding). * Hemodynamic instability despite vasopressors (SBP \< 90 mmHg or MAP \< 60 mmHg for \> 30 minutes after ROSC and before enrollment). * Bradycardia (HR\<60/min) * Allergy against MgSO4 * AV-block * Myasthenia gravis * Known terminal renal insufficiency (creatinine-clearance \< 20ml/min) * Severe myocardial dysfunction (EF\<25%) * Chronic digitalis therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cooling rate from start of cooling until a temperature of 34°C is reached | Approximately 10 to 60 minutes after start of cooling |
Secondary
| Measure | Time frame |
|---|---|
| Survival | To 24 hours, hospital discharge, and 30 days |
| Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis | During hospital stay |
| Adverse events, serious adverse events, device-related adverse events | From enrollment through 6-month follow-up |
| Blood pressure and ECGs | Through hospital stay |
| Serum chemistry parameters (standard chemistry panel) | Through hospital stay |
| Hematology parameters | Through hospital stay |
| Percentage of time of the maintenance phase where the patient core temperature is between 32.0 and 34.0°C. | Approximately 12 hours after initial cooling |
| Incidence of shivering during cooling and maintenance of hypothermia | Approximately 12 hours after cooling |
| Duration of maintenance of hypothermia without supplemental cooling | Approximately 12 hours after cooling |
| Total number of days in ICU | Generally less than 30 days |
| Neurologic and physical status | At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment |
| Time from collapse to a core temperature < 34.0°C | Approximately 30 to 180 minutes |
Countries
Austria
Outcome results
None listed