Clinical trial NCT00593164: Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate
Official title: Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Death, Sudden, Cardiac
Coma
Keywords: Hypothermia, Induced
Death, Sudden, Cardiac
Resuscitation
Coma
Lead sponsor: Life Recovery Systems
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2008-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cooling rate from start of cooling until a temperature of 34°C is reached
timeFrame: Approximately 10 to 60 minutes after start of cooling
Secondary outcomes:
measure: Time from collapse to a core temperature < 34.0°C
timeFrame: Approximately 30 to 180 minutes
measure: Percentage of time of the maintenance phase where the patient core temperature is between 32.0 and 34.0°C.
timeFrame: Approximately 12 hours after initial cooling
measure: Incidence of shivering during cooling and maintenance of hypothermia
timeFrame: Approximately 12 hours after cooling
measure: Duration of maintenance of hypothermia without supplemental cooling
timeFrame: Approximately 12 hours after cooling
measure: Total number of days in ICU
timeFrame: Generally less than 30 days
measure: Neurologic and physical status
timeFrame: At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment
measure: Adverse events, serious adverse events, device-related adverse events
timeFrame: From enrollment through 6-month follow-up
measure: Blood pressure and ECGs
timeFrame: Through hospital stay
measure: Serum chemistry parameters (standard chemistry panel)
timeFrame: Through hospital stay
measure: Hematology parameters
timeFrame: Through hospital stay
measure: Survival
timeFrame: To 24 hours, hospital discharge, and 30 days
measure: Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis
timeFrame: During hospital stay
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Emergency Medicine, Medical University of Vienna
Study officials:
affiliation: Department of Emergency Medicine, Medical University of Vienna
name: Michael Holzer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: