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

Life Recovery Systems

Status and phase: Withdrawn; Phase 2

Conditions: Coma; Death, Sudden, Cardiac

Treatments: Device: Cooling with ThermoSuit with Normal Saline Infusion; Device: Cooling with ThermoSuit with Magnesium Sulfate Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00593164

LRS-01-07-02

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

1

Experimental group

Description:

Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min).

Treatment:

Device: Cooling with ThermoSuit with Magnesium Sulfate Infusion

2

Active Comparator group

Description:

Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous normal saline.

Treatment:

Device: Cooling with ThermoSuit with Normal Saline Infusion