Coma Clinical Trial
Official title:
Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate
Verified date | August 2017 |
Source | Life Recovery Systems |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Emergency Medicine, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Life Recovery Systems | Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cooling rate from start of cooling until a temperature of 34°C is reached | Approximately 10 to 60 minutes after start of cooling | ||
Secondary | Time from collapse to a core temperature < 34.0°C | Approximately 30 to 180 minutes | ||
Secondary | 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 | ||
Secondary | Incidence of shivering during cooling and maintenance of hypothermia | Approximately 12 hours after cooling | ||
Secondary | Duration of maintenance of hypothermia without supplemental cooling | Approximately 12 hours after cooling | ||
Secondary | Total number of days in ICU | Generally less than 30 days | ||
Secondary | Neurologic and physical status | At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment | ||
Secondary | Adverse events, serious adverse events, device-related adverse events | From enrollment through 6-month follow-up | ||
Secondary | Blood pressure and ECGs | Through hospital stay | ||
Secondary | Serum chemistry parameters (standard chemistry panel) | Through hospital stay | ||
Secondary | Hematology parameters | Through hospital stay | ||
Secondary | Survival | To 24 hours, hospital discharge, and 30 days | ||
Secondary | Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis | During hospital stay |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03700125 -
Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 )
|
N/A | |
Active, not recruiting |
NCT02244853 -
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
|
N/A | |
Active, not recruiting |
NCT00661128 -
Genomics of Sudden Cardiac Arrest
|
||
Withdrawn |
NCT00573092 -
Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs
|
N/A | |
Completed |
NCT00376532 -
Extracellular Matrix Marker of Arrhythmia Risk (EMMA)
|
N/A | |
Completed |
NCT00241800 -
Medications and the Risk of Sudden Cardiac Death
|
N/A | |
Completed |
NCT00047411 -
Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
|
Phase 3 | |
Completed |
NCT00399503 -
Assessment of Noninvasive Methods to Identify Patients at Risk of Serious Arrhythmias After a Heart Attack
|
N/A | |
Completed |
NCT00004560 -
Public Access Defibrillation (PAD) Community Trial
|
Phase 3 | |
Completed |
NCT00000531 -
Antiarrhythmics Versus Implantable Defibrillators (AVID)
|
Phase 3 | |
Completed |
NCT00000480 -
Multicenter Unsustained Tachycardia Trial (MUSTT)
|
Phase 3 | |
Completed |
NCT00005265 -
Natural History of Coronary Heart Disease
|
N/A | |
Completed |
NCT00000492 -
Beta-Blocker Heart Attack Trial (BHAT)
|
Phase 3 | |
Completed |
NCT01949025 -
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
|
N/A | |
Completed |
NCT01789554 -
The Use of Mobile Phones in Out of Hospital Cardiac Arrest to Increase Bystander CPR
|
N/A | |
Completed |
NCT00382928 -
Automatic External Defibrillation Monitoring in Cardiac Arrest
|
Phase 1 | |
Terminated |
NCT00189423 -
ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest
|
N/A | |
Completed |
NCT04132466 -
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
|
N/A | |
Completed |
NCT00000609 -
Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
|
Phase 3 | |
Completed |
NCT03065647 -
ECPR for Refractory Out-Of-Hospital Cardiac Arrest
|
N/A |