A Randomised, Double-blinded Multi-centre Trial Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest at the Emergency Department. (Preadmission Intravenous Vasopressin, Adrenaline Outcome Trial: PIVOT vII)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 727
- 试验地点
- 4
- 主要终点
- Survival to Hospital Discharge.
研究概览
简要总结
The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.
Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of cardiac arrest to answer the question whether there is an improvement in survival between vasopressin and adrenaline.
详细描述
The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the recommended drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.
More recently, vasopressin has been used in patients with cardiac arrest. In human studies on vasopressin, clinical trials have produced conflicting results.
The current study compared vasopressin and adrenaline in the treatment of cardiac arrest in patients presenting to the Emergency Department (ED). Specific outcomes included return of spontaneous circulation (ROSC) (as measured by the presence of a palpable pulse at any time during resuscitation), survival to hospital admission, survival to discharge from hospital, and functional status at discharge and at one year (as measured by the Glasgow-Pittsburgh outcome categories).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea
- •Age above 16 (Age 21 and above for CGH only)
排除标准
- •Traumatic cardiac arrest
- •Age 16 and below (Age 20 and below for CGH only)
- •CPR is contraindicated
研究组 & 干预措施
Adrenaline
干预措施: Adrenaline (Drug)
Vasopressin
干预措施: Vasopressin (Drug)
结局指标
主要结局
Survival to Hospital Discharge.
时间窗: at 30 days post arrest
Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first.
次要结局
- Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.(at 30 days post arrest)
- Neurological Status at 1 Year.(at 1 year post arrest)
- Return of Spontaneous Circulation.(during resuscitation)
- Survival to Admission.(No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards)