Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate
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|ClinicalTrials.gov Identifier: NCT00593164|
Recruitment Status : Withdrawn (Funding for study is currently unavailable.)
First Posted : January 14, 2008
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Death, Sudden, Cardiac Coma||Device: Cooling with ThermoSuit with Magnesium Sulfate Infusion Device: Cooling with ThermoSuit with Normal Saline Infusion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate|
|Anticipated Study Start Date :||September 2017|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||April 2018|
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).
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593164
|Department of Emergency Medicine, Medical University of Vienna|
|Vienna, Austria, A-1090|
|Principal Investigator:||Michael Holzer, M.D.||Department of Emergency Medicine, Medical University of Vienna|