Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 584
- 试验地点
- 27
- 主要终点
- Neurological outcome assessed with Cerebral Performance Category scale
研究概览
简要总结
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.
There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 in non shockable rhythm
- •Glasgow score ≤ 8
排除标准
- •No flow > 10 min
- •Low flow > 60 min
- •Major hemodynamic instability
- •Delay between cardiac arrest and inclusion > 300 min
- •Cirrhosis Child C
- •Age < 18 years
- •Pregnant women
- •Patient with no liberty
- •Lack of informed consent
- •Prior inclusion in a research protocol involving cardiac arrest with draw, and whose primary endpoint focuses on the evaluation of a neurological score Day 90
研究组 & 干预措施
Targeted controlled temperature between 32.5 and 33.5°C
Patients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours.
干预措施: Targeted controlled temperature between 32.5 and 33.5°C (Procedure)
Targeted controlled temperature between 32.5 and 33.5°C
Patients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours.
干预措施: Targeted controlled temperature between 36.5 and 37.5°C (Procedure)
Targeted controlled temperature between 36.5 and 37.5°C
Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours.
干预措施: Targeted controlled temperature between 36.5 and 37.5°C (Procedure)
结局指标
主要结局
Neurological outcome assessed with Cerebral Performance Category scale
时间窗: Day 90
次要结局
- Intensive Care Unit Mortality(Discharge from Intensive Care Unit, an expected average of 7 days)
- Hospital Mortality(Discharge from hospital, an expected average of 2 weeks)
- Mortality at day 90(Day 90)
- Quality of life Score(Day 90)
- Life autonomy(Day 90)
- Neurocognitive evaluation(Day 90)
- Post traumatic stress disorders symptoms(Day 90)
- Intensive Care Unit length of stay(Discharge from Intensive Care Unit, an expected average of 7 days)
- Hospital length of stay(Discharge from hospital, an expected average of 2 weeks)
- Mechanical ventilation duration(Time from extubation, an expected average of 4 days)
- Severe hemorrhage(Intensive care unit length of stay, an expected average of 7 days)
- Nosocomial Bloodstream infection(Intensive care unit length of stay, an expected average of 7 days)
- Early onset pneumonia(2 days)
- Ventilated Associated Pneumonia(Duration of mechanical ventilation, an expected average of 4 days)
- Central Veinous Catheter infection(Intensive care unit length of stay, an expected average of 7 days)
- Total dose of inotropic drugs(48 hours)
- Extra renal support requirement(Intensive care unit length of stay, an expected 7 days)
- Acute pulmonary oedema by left ventricular failure(Intensive care length of stay, an expected 7 days)
- Seizure(Intensive care length of stay, an expected 7 days)
- Severe arrythmia(Intensive care unit length of stay, an expected 7 days)