Death, Sudden, CardiacPhase 2NCT00593164
Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate
A Phase 2 study testing Cooling with ThermoSuit with Magnesium Sulfate Infusion and Cooling with ThermoSuit with Normal Saline Infusion in people with Death, Sudden, Cardiac and Coma, run by Life Recovery Systems at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Sudden, Cardiac, Coma
- What is being tested?
- Cooling with ThermoSuit with Magnesium Sulfate Infusion and Cooling with ThermoSuit with Normal Saline Infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2017to Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Emergency Medicine, Medical University of Vienna
Vienna, A-1090
About this study
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.
Read the 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.
- Conditions
- Death, Sudden, Cardiac, Coma
- Being tested
- Cooling with ThermoSuit with Magnesium Sulfate Infusion, Cooling with ThermoSuit with Normal Saline Infusion
- Keywords
- Hypothermia, Induced, Death, Sudden, Cardiac, Resuscitation, Coma
- Medical subject headings
- Death, Sudden, Cardiac, Coma, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling with ThermoSuit with Magnesium Sulfate InfusionDevice
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).
Cooling with ThermoSuit with Normal Saline InfusionDevice
Cooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min). Receives: Device: Cooling with ThermoSuit with Magnesium Sulfate Infusion |
| 2 | Active comparator | Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous normal saline. Receives: Device: Cooling with ThermoSuit with Normal Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cooling rate from start of cooling until a temperature of 34°C is reached
Measured: Approximately 10 to 60 minutes after start of cooling
Secondary outcomes (12)
Time from collapse to a core temperature < 34.0°C
Measured: 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.
Measured: Approximately 12 hours after initial cooling
Incidence of shivering during cooling and maintenance of hypothermia
Measured: Approximately 12 hours after cooling
Duration of maintenance of hypothermia without supplemental cooling
Measured: Approximately 12 hours after cooling
Total number of days in ICU
Measured: Generally less than 30 days
Neurologic and physical status
Measured: At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment
Adverse events, serious adverse events, device-related adverse events
Measured: From enrollment through 6-month follow-up
Blood pressure and ECGs
Measured: Through hospital stay
Serum chemistry parameters (standard chemistry panel)
Measured: Through hospital stay
Hematology parameters
Measured: Through hospital stay
Survival
Measured: To 24 hours, hospital discharge, and 30 days
Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis
Measured: During hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startSep 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Funding for study is currently unavailable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Recovery Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
- Investigators
- Michael Holzer, M.D., Principal investigator, Department of Emergency Medicine, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593164
- Sponsor's protocol ID
- LRS-01-07-02
- Status last verified
- Aug 2017
- First submitted
- 28 Dec 2007
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate
- ClinicalTrials.gov ID
- NCT00593164
- Acronym / sponsor ID
- LRS-01-07-02
- Conditions
- Death, Sudden, Cardiac, Coma
- Keywords
- Hypothermia, Induced, Death, Sudden, Cardiac, Resuscitation, Coma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for study is currently unavailable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Life Recovery SystemsUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- Sep 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Cooling with ThermoSuit with Magnesium Sulfate InfusionComatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min). |
| 2 | Active comparator | Device: Cooling with ThermoSuit with Normal Saline InfusionComatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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].
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling with ThermoSuit with Magnesium Sulfate InfusionCooling 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). | Device | 1 |
| Cooling with ThermoSuit with Normal Saline InfusionCooling with LRS ThermoSuit within 15 minutes of normal saline infusion (100 ml of normal NaCl solution, given over 15 min). | Device | 2 |
Primary outcome
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
12 secondary outcomes
Time from collapse to a core temperature < 34.0°C
Time frame: 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.
Time frame: Approximately 12 hours after initial cooling
Incidence of shivering during cooling and maintenance of hypothermia
Time frame: Approximately 12 hours after cooling
Duration of maintenance of hypothermia without supplemental cooling
Time frame: Approximately 12 hours after cooling
Total number of days in ICU
Time frame: Generally less than 30 days
Neurologic and physical status
Time frame: At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment
Adverse events, serious adverse events, device-related adverse events
Time frame: From enrollment through 6-month follow-up
Blood pressure and ECGs
Time frame: Through hospital stay
Serum chemistry parameters (standard chemistry panel)
Time frame: Through hospital stay
Hematology parameters
Time frame: Through hospital stay
Survival
Time frame: To 24 hours, hospital discharge, and 30 days
Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis
Time frame: During hospital stay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Holzer, M.D. principal investigator
Department of Emergency Medicine, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cooling with ThermoSuit with Magnesium Sulfate Infusion and Cooling with ThermoSuit with Normal Saline Infusion in people with Death, Sudden, Cardiac and Coma, run by Life Recovery Systems at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.