Post resusucitation disease after resuscitation from cardiac arrest MedDRA version: 9.1 Level: LLT Classification code 10007515 Term: Cardiac arrest MedDRA version: 9.1 Level: LLT Classification code 10029286 Term: Neurologic disorder NOS MedDRA version: 9.1 Level: LLT Classification code 10059485 Term: Therapeutic hypothermia
Conditions
Interventions
Trade Name: Cormagnesin
Product Name: Magnesium Sulfate
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo
Sponsors
Life Recovery Systems
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC). 2. Estimated or known age > 18 years. 3. Intubation, ventilation and placement of esophageal temperature probe. 4. Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS = 8]. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Height greater than 188 cm. 2. Elbow-to-elbow width greater than 60 cm (as measured above the supine patient). 3. Core temperature less than 35°C after ROSC (as measured in the esophagus). 4. Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system. 5. Known pregnancy. 6. Known terminal illness that preceded the arrest. 7. Known enrollment in another study of a device, drug, or biologic. 8. Major trauma or other co-morbidity requiring urgent surgery. 9. > 4 hours since return of spontaneous circulation. 10. Severe coagulopathy (with active bleeding). 11. Hemodynamic instability despite vasopressors (SBP 30 minutes after ROSC and before enrollment). 12. Bradycardia (HR<60/min) 13. Allergy against MgSo4 14. AV-block 15. Myasthenia gravis 16. Known terminal renal insufficiency (creatinine-clearence < 20ml/min) 17. Severe myocardial dysfunction (EF<25%) 18. Chronic digitalis therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of MgSO4 on time to achieving the target temperature with the ThermoSuit™ System.;Secondary Objective: - To assess the ease and feasibility of implementing a therapeutic hypothermia protocol [including an externally applied LRS ThermoSuit™ (Life Recovery Systems HD, L.L.C., Kinnelon, NJ, USA) cooling system] to unconscious patients following resuscitation from an out-of-hospital or in-hospital cardiac arrest. - To evaluate the incidence of adverse events (total and serious) associated with the ThermoSuit™ in conjunction with the use of MgSO4 . - To evaluate the impact of MgSO4 on hemodynamics during and after the use of the ThermoSuit System. - To determine the duration a core target temperature range of 32-43°C is maintained before further interventions are required to avoid spontaneous re-warming. - To assess clinical (ICU and hospital mortality and length of stay (LOS), neurologic recovery at discharge) outcomes in patients treated with therapeutic hypothermia using the LRS ThermoSuit™. ;Primary end point(s): Cooling rate from start of cooling until a temperature of 34°C is reached as calculated by the formula: (Tempstart-34)/(Time34°C-Timestart) | — |
Countries
Austria
Outcome results
None listed