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

NCT ID: NCT00593164

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2018-04-30

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.

Conditions

Death, Sudden, Cardiac; Coma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Cooling with ThermoSuit with Magnesium Sulfate Infusion

Intervention Type: DEVICE

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).

2

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

Group Type: ACTIVE_COMPARATOR

Cooling with ThermoSuit with Normal Saline Infusion

Intervention Type: DEVICE

Cooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min).

Interventions

Cooling 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).

Intervention Type: DEVICE

Cooling 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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

Life Recovery Systems

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Holzer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, Medical University of Vienna

Locations

Department of Emergency Medicine, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

LRS-01-07-02

Identifier Type: -

Identifier Source: org_study_id