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

Coma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00593164
• Other study ID #: LRS-01-07-02
• Status: Withdrawn
• Phase: Phase 2
• First received: December 28, 2007
• Last updated: August 23, 2017
• Start date: September 2017
• Est. completion date: April 2018

Study information

• Verified date: August 2017
• Source: Life Recovery Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coma
• Death, Sudden
• Death, Sudden, Cardiac

Intervention

Device:
• 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).
• 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).

Locations

Country	Name	City	State
Austria	Department of Emergency Medicine, Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Life Recovery Systems	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cooling rate from start of cooling until a temperature of 34°C is reached		Approximately 10 to 60 minutes after start of cooling
Secondary	Time from collapse to a core temperature < 34.0°C		Approximately 30 to 180 minutes
Secondary	Percentage of time of the maintenance phase where the patient core temperature is between 32.0 and 34.0°C.		Approximately 12 hours after initial cooling
Secondary	Incidence of shivering during cooling and maintenance of hypothermia		Approximately 12 hours after cooling
Secondary	Duration of maintenance of hypothermia without supplemental cooling		Approximately 12 hours after cooling
Secondary	Total number of days in ICU		Generally less than 30 days
Secondary	Neurologic and physical status		At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment
Secondary	Adverse events, serious adverse events, device-related adverse events		From enrollment through 6-month follow-up
Secondary	Blood pressure and ECGs		Through hospital stay
Secondary	Serum chemistry parameters (standard chemistry panel)		Through hospital stay
Secondary	Hematology parameters		Through hospital stay
Secondary	Survival		To 24 hours, hospital discharge, and 30 days
Secondary	Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis		During hospital stay