Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate

Status: Withdrawn
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 \[GCS ≤ 8\].

Locations
Other Locations
Austria
Department of Emergency Medicine, Medical University of Vienna
Vienna
Time Frame
Start Date: 2017-09
Completion Date: 2018-04
Treatments
Experimental: 1
Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min).
Active_comparator: 2
Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous normal saline.
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of Vienna
Leads: Life Recovery Systems

This content was sourced from clinicaltrials.gov