NCT02035839已完成不适用
A Pilot Multicenter Randomized Trial on the Effectiveness of Different Levels of Cooling in Comatose Survivors of Out-of-hospital Cardiac Arrest.
ZOLL Circulation, Inc., USA20 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2014年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 20
- 主要终点
- Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest.
研究概览
简要总结
To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent (obtained from their legal representative)
- •18 years of age or older and less than 80 years old.
- •Witnessed OHCA of presumed cardiac cause
- •Sustained ROSC (when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist)
- •Initial shockable cardiac rhythm (documented by ECG or AED)
- •Interval from collapse to advance life support < 20 minutes
- •Interval from collapse to ROSC < 60 minutes
- •Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
- •Systolic blood pressure of >90 maintained for a least 30 minutes post-ROSC without pressors, or with a stable dose of pressors
排除标准
- •Traumatic cardiac arrest
- •Toxicological etiology
- •Known or suspected pregnancy
- •Do Not Attempt to Resuscitate order in force
- •Unwitnessed arrest
- •In-Hospital arrest
- •Anatomy, previous surgery or disease state contraindicating femoral venous access
- •Received neuromuscular blocking agents prior to assessing level of consciousness following ROSC
- •Neurological evaluation insufficient/incomplete after ROSC but prior to randomization.
- •Body core temperature < 34ºC at randomization
- •Current Inferior Vena Cava (IVC) filter
- •Known history of acute neurological illness or severe functional disabilities prior to arrest (e.g., seizures, traumatic brain injury, increased intracranial pressures, intra-cerebral hemorrhage, etc).
- •Known hypersensitivity to hypothermia including a history of Raynaud's disease
- •Suspected or confirmed acute intracranial bleeding
- •Suspected or confirmed acute stroke
- •Terminal illness or life expectancy of less than 3 months prior to arrest
- •Currently enrolled in another investigational new drug or device trial that has not completed the primary endpoint or that clinically interferes with this Trial's endpoints (For the purpose of this protocol, subjects involved in extended follow-up trials or registries for products that are currently commercially available are not considered enrolled in an investigational trial).
- •Transferred from a non-participating hospital.
研究组 & 干预措施
Target Temperature Management of 34°C
Other
In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.
干预措施: Target Temperature Management of 34°C (Device)
Target Temperature Management of 32°C
Other
In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.
干预措施: Target Temperature Management of 32°C (Device)
Target Temperature Management of 33°C
Other
In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.
干预措施: Target Temperature Management of 33°C (Device)
结局指标
主要结局
Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest.
时间窗: at 90 days after out-of-hospital cardiac arrest
次要结局
- Observational status of arrest(Witnessed by EMS; Witnessed by bystanders)
- Outcomes: 1.Favorable neurologic status at 90 days (i.e. mRS < 3) measured as proportion(90 days)
- Outcomes: 8. Hospital-free survival within 90 days measured in days(90 days)
- Treatment Success: 2. proportion of time at randomly allocated target temperature ±0.3°C during first 24 hours after initiation of induction of hypothermia(24 hours)
- Outcomes: 3.Robust neurologic status at 90 days (i.e. mRS < 2) measured as proportion(90 days)
- Treatment Success: 3. time to randomly allocated target temperature, from call to 911, sustained restoration of circulation and initiation of induction of hypothermia(26 hours)
- Outcomes: 2.Time to first detected mRS ≤3 (i.e. Kaplan Meier curve)(90 days)
- Outcomes: 6. Cumulative incidence of survival at 90 days (i.e. Kaplan Meier curve)(90 days)
- Outcomes: 4. Time to first detected mRS ≤2 (i.e. Kaplan Meier curve)(90 days)
- Treatment Success: 5. rate of rewarming in °C per hour(Per hour)
- Subgroups of Special Interest Age of Patients(Duration of the trial)
- Treatment Success: 1. proportion of subjects that can be therapeutically cooled to randomly allocated target temperature ±0.3°C (as measured by the temperature probe)(24 hours)
- Treatment Success: 4. rate of cooling in °C per hour(Per hour)
- Outcomes: 5. Survival at 90 days measured as proportion(90 days)
- Outcomes: 7. ICU-free survival within 90 days measured in days(90 days)
- Outcomes: 9. Adverse events a. Device related b. Procedure related(90 days)
- Subgroup analysis(1 year)
- Timings of initiation of hypothermia(<4 hours of restoration of spontaneous circulation; or > 4 hours)
- Patient Gender(Male or Female)
- Response time interval from call to initiation of CPR by EMS, among witnessed arrests:(< 10 minutes;> 10 minutes.)
- Location of cardiac arrest(Public;Home; or Group residence (e.g. nursing home))
- Bystander CPR status:(Performed; or Not performed.)
- AED status:(Applied by layperson;Applied by EMS provider;Not applied)
研究者
研究点 (20)
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