Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients With Intravenous Infusion of Magnesium Sulfate
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Cooling rate from start of cooling until a temperature of 34°C is reached
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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].
排除标准
- •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
- •Myasthenia gravis
- •Known terminal renal insufficiency (creatinine-clearance < 20ml/min)
- •Severe myocardial dysfunction (EF<25%)
- •Chronic digitalis therapy
研究组 & 干预措施
1
Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous magnesium sulfate (30 mg per kg IV over 15 min).
干预措施: Cooling with ThermoSuit with Magnesium Sulfate Infusion (Device)
2
Comatose post-resuscitation patients cooled with ThermoSuit and treated with intravenous normal saline.
干预措施: Cooling with ThermoSuit with Normal Saline Infusion (Device)
结局指标
主要结局
Cooling rate from start of cooling until a temperature of 34°C is reached
时间窗: Approximately 10 to 60 minutes after start of cooling
次要结局
- Blood pressure and ECGs(Through hospital stay)
- Incidence of shivering during cooling and maintenance of hypothermia(Approximately 12 hours after cooling)
- Adverse events, serious adverse events, device-related adverse events(From enrollment through 6-month follow-up)
- Hematology parameters(Through hospital stay)
- Duration of maintenance of hypothermia without supplemental cooling(Approximately 12 hours after cooling)
- Neurologic and physical status(At discharge, 30 +/- 7 days, and 6 months +/- 15 days after initial treatment)
- Serum chemistry parameters (standard chemistry panel)(Through hospital stay)
- Survival(To 24 hours, hospital discharge, and 30 days)
- Rate of infection (respiratory, skin, and invasive access sites) and rate of sepsis(During hospital stay)
- 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)
- Total number of days in ICU(Generally less than 30 days)