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

Sponsored by:	Life Recovery Systems
Information provided by:	Life Recovery Systems
ClinicalTrials.gov Identifier:	NCT00593164

Purpose

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.

Condition	Intervention	Phase
Death, Sudden, Cardiac Coma	Device: Cooling with ThermoSuit with Magnesium Sulfate Infusion Device: Cooling with ThermoSuit with Normal Saline Infusion	Phase II

MedlinePlus related topics: Cardiac Arrest Hypothermia

Drug Information available for: Magnesium sulfate Magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate

Further study details as provided by Life Recovery Systems:

Primary Outcome Measures:

Cooling rate from start of cooling until a temperature of 34°C is reached [ Time Frame: Approximately 10 to 60 minutes after start of cooling ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from collapse to a core temperature < 34.0°C [ Time Frame: Approximately 30 to 180 minutes ] [ Designated as safety issue: No ]
Percentage of time of the maintenance phase where the patient core temperature is between 32.0 and 34.0°C. [ Time Frame: Approximately 12 hours after initial cooling ] [ Designated as safety issue: No ]
Incidence of shivering during cooling and maintenance of hypothermia [ Time Frame: Approximately 12 hours after cooling ] [ Designated as safety issue: No ]
Duration of maintenance of hypothermia without supplemental cooling [ Time Frame: Approximately 12 hours after cooling ] [ Designated as safety issue: No ]
Total number of days in ICU [ Time Frame: Generally less than 30 days ] [ Designated as safety issue: No ]
Neurologic and physical status [ Time Frame: At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment ] [ Designated as safety issue: Yes ]
Adverse events, serious adverse events, device-related adverse events [ Time Frame: From enrollment through 6-month follow-up ] [ Designated as safety issue: Yes ]
Blood pressure and ECGs [ Time Frame: Through hospital stay ] [ Designated as safety issue: Yes ]
Serum chemistry parameters (standard chemistry panel) [ Time Frame: Through hospital stay ] [ Designated as safety issue: Yes ]
Hematology parameters [ Time Frame: Through hospital stay ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: To 24 hours, hospital discharge, and 30 days ] [ Designated as safety issue: Yes ]
Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis [ Time Frame: During hospital stay ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	14
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min).	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).
2: Active Comparator Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous normal saline.	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).

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593164

Locations

Austria
Department of Emergency Medicine, Medical University of Vienna
Vienna, Austria, A-1090

Sponsors and Collaborators

Life Recovery Systems

Investigators

Principal Investigator:

Michael Holzer, M.D.

Department of Emergency Medicine, Medical University of Vienna

More Information

No publications provided

Responsible Party:	Life Recovery Systems ( Robert B. Schock/Vice President, Research and Development )
Study ID Numbers:	LRS-01-07-02
Study First Received:	December 28, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00593164 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Life Recovery Systems:

Hypothermia, Induced
Death, Sudden, Cardiac
Resuscitation
Coma

Study placed in the following topic categories:

Hypothermia
Death
Heart Diseases
Magnesium Sulfate
Calcium Channel Blockers
Anesthetics
Central Nervous System Depressants
Heart Arrest
Cardiovascular Agents

Coma
Calcium, Dietary
Death, Sudden
Death, Sudden, Cardiac
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Anticonvulsants

Additional relevant MeSH terms:

Death
Molecular Mechanisms of Pharmacological Action
Magnesium Sulfate
Physiological Effects of Drugs
Anesthetics
Calcium Channel Blockers
Reproductive Control Agents
Membrane Transport Modulators
Pathologic Processes
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases

Analgesics
Death, Sudden, Cardiac
Anti-Arrhythmia Agents
Heart Diseases
Central Nervous System Depressants
Heart Arrest
Cardiovascular Agents
Pharmacologic Actions
Death, Sudden
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009