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

NCT00593164 | Withdrawn Phase 2 DMC

• 1 other identifier: LRS-01-07-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Death, Sudden, Cardiac; Coma

Keywords

Hypothermia, Induced; Death, Sudden, Cardiac; Resuscitation; Coma

Outcome Measures

Primary Outcomes (1)

• Cooling rate from start of cooling until a temperature of 34°C is reached

  Approximately 10 to 60 minutes after start of cooling

Secondary Outcomes (12)

• 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

Study Arms (2)

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

2

ACTIVE COMPARATOR

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

Device: Cooling with ThermoSuit with Normal Saline Infusion

Interventions

Cooling with ThermoSuit with Magnesium Sulfate Infusion 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).

1

Cooling with ThermoSuit with Normal Saline Infusion DEVICE

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[GCS ≤ 8\].

You may not qualify if:

• 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

Sponsors & Collaborators

• Life Recovery Systems: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Department of Emergency Medicine, Medical University of Vienna

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Coma; Hypothermia

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Body Temperature Changes

Study Officials

• Michael Holzer, M.D.

  Department of Emergency Medicine, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: September 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

AU (1)