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

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.

Study Overview

• Status: Withdrawn
• Conditions: Coma; Death, Sudden, Cardiac
• Intervention / Treatment: Device: Cooling with ThermoSuit with Magnesium Sulfate Infusion; Device: Cooling with ThermoSuit with Normal Saline Infusion

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cooling rate from start of cooling until a temperature of 34°C is reached	Approximately 10 to 60 minutes after start of cooling

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from collapse to a core temperature < 34.0°C	Approximately 30 to 180 minutes
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
Incidence of shivering during cooling and maintenance of hypothermia	Approximately 12 hours after cooling
Duration of maintenance of hypothermia without supplemental cooling	Approximately 12 hours after cooling
Total number of days in ICU	Generally less than 30 days
Neurologic and physical status	At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment
Adverse events, serious adverse events, device-related adverse events	From enrollment through 6-month follow-up
Blood pressure and ECGs	Through hospital stay
Serum chemistry parameters (standard chemistry panel)	Through hospital stay
Hematology parameters	Through hospital stay
Survival	To 24 hours, hospital discharge, and 30 days
Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis	During hospital stay

Collaborators and Investigators

• Sponsor: Life Recovery Systems
• Collaborators: Medical University of Vienna
• Investigators: Principal Investigator: Michael Holzer, M.D., Department of Emergency Medicine, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: January 11, 2008
• First Posted (Estimate): January 14, 2008

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Resuscitation; Coma; Hypothermia, Induced; Death, Sudden, Cardiac
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death; Heart Arrest; Death, Sudden, Cardiac; Death, Sudden; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: LRS-01-07-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No