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

This study is not yet open for participant recruitment.
Verified February 2012 by Life Recovery Systems
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Life Recovery Systems
ClinicalTrials.gov Identifier:
NCT00593164
First received: December 28, 2007
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate

Resource links provided by NLM:

U.S. FDA Resources

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: November 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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).
Active Comparator: 2
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 Not yet recruiting
Vienna, Austria, A-1090
Contact: Michael Holzer, M.D.     436642632869     michael.holzer@meduniwien.ac.at    
Contact: Andreas Janata, M.D.     436509567795     andreas.janata@meduniwien.ac.at    
Principal Investigator: Michael Holzer, M.D.            
Sub-Investigator: Andreas Janata, M.D.            
Sponsors and Collaborators
Life Recovery Systems
Medical University of Vienna
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
ClinicalTrials.gov Identifier: NCT00593164     History of Changes
Other Study ID Numbers: LRS-01-07-02
Study First Received: December 28, 2007
Last Updated: February 1, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Life Recovery Systems:
Hypothermia, Induced
Death, Sudden, Cardiac
Resuscitation
Coma

Additional relevant MeSH terms:
Coma
Death
Death, Sudden
Death, Sudden, Cardiac
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Magnesium Sulfate
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013