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

Primary Purpose

Death, Sudden, Cardiac, Coma

Status

Withdrawn

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Cooling with ThermoSuit with Magnesium Sulfate Infusion

Cooling with ThermoSuit with Normal Saline Infusion

About this trial

This is an interventional treatment trial for Death, Sudden, Cardiac focused on measuring Hypothermia, Induced, Death, Sudden, Cardiac, Resuscitation, Coma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Emergency Medicine, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time from collapse to a core temperature < 34.0°C

Percentage of time of the maintenance phase where the patient core temperature is between 32.0 and 34.0°C.

Incidence of shivering during cooling and maintenance of hypothermia

Duration of maintenance of hypothermia without supplemental cooling

Total number of days in ICU

Neurologic and physical status

Adverse events, serious adverse events, device-related adverse events

Blood pressure and ECGs

Serum chemistry parameters (standard chemistry panel)

Hematology parameters

Survival

Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis

Full Information

NCT ID

NCT00593164

First Posted

December 28, 2007

Last Updated

August 23, 2017

Sponsor

Life Recovery Systems

Collaborators

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00593164

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Funding for study is currently unavailable.

Study Start Date

September 2017 (Anticipated)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Life Recovery Systems

Collaborators

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Death, Sudden, Cardiac, Coma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min).

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Cooling with ThermoSuit with Magnesium Sulfate Infusion

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Cooling with ThermoSuit with Normal Saline Infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time from collapse to a core temperature < 34.0°C

Time Frame

Approximately 30 to 180 minutes

Title

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

Title

Incidence of shivering during cooling and maintenance of hypothermia

Time Frame

Approximately 12 hours after cooling

Title

Duration of maintenance of hypothermia without supplemental cooling

Time Frame

Approximately 12 hours after cooling

Title

Total number of days in ICU

Time Frame

Generally less than 30 days

Title

Neurologic and physical status

Time Frame

At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment

Title

Adverse events, serious adverse events, device-related adverse events

Time Frame

From enrollment through 6-month follow-up

Title

Blood pressure and ECGs

Time Frame

Through hospital stay

Title

Serum chemistry parameters (standard chemistry panel)

Time Frame

Through hospital stay

Title

Hematology parameters

Time Frame

Through hospital stay

Title

Survival

Time Frame

To 24 hours, hospital discharge, and 30 days

Title

Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis

Time Frame

During hospital stay

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Holzer, M.D.

Organizational Affiliation

Department of Emergency Medicine, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Emergency Medicine, Medical University of Vienna

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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