VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,276
- 试验地点
- 2
- 主要终点
- Survival at 30 days
研究概览
简要总结
This is an investigator initiated randomized, placebo controlled, double blind, superiority, multi-centre clinical trial. The estimated study project period runs over 3-4 years, including pilot phase. Based on preliminary assumptions, to confirm or reject an increase in survival from 9% to 14%, about1400 patients will be randomized in the study. In hospital cardiac arrest patients meeting criteria(s) for adrenaline administration according to current ERC guidelines are eligible for randomization in the study.
Informed consent for participating in the study cannot be obtained from the subject at the scene of the cardiac arrest since the victim is unconscious. Therefore, all hospitalized men > 18 years and women > 50 years, except those fulfilling the exclusion criterias; patients not capable to comprehend information to decide about participation in the study, women considered of childbearing potential (WOCBP)) and do not resuscitate (DNR) decision will be informed and asked about consent to participate in the study and in the case of cardiac arrest during the actual hospital stay randomized to either treatment. Only those patients experiencing an in hospital cardiac arrest meeting criteria(s) for adrenaline administration will be randomized.
Patients will be randomized to, in addition adrenaline, either treatment with vasopressin and steroids (intervention) or sodium chloride (placebo) (control).
Primary outcome is survival at 30 days.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Hospitalized men > 18 years and hospitalized women > 50 years.
排除标准
- •Patients not capable to comprehend information to decide about participation in the study
- •Women considered of childbearing potential (WOCBP) i. e. premenopausal women
- •Patients with do not resuscitate (DNR) descision
- •Prior enrollment and randomization in the trial
研究组 & 干预措施
Intervention
Adrenaline, vasopressin and steroids arm (intervention)
- At randomization
1 ml of vasopressin 20 IU/ml will be administered as soon as possible after adrenaline during the five first cycles of drug administration during CPR.
1 ml metylprednisolone sodium succinate 40 mg/ml will be administered only during the first cycle of drug administration during CPR 2. In the ICU Hydrocortisone 3 mg/ml At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml (300 mg hydrocortisone/ d) for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the hydrocortisone dos will be reduced daily to 67 ml (200 mg) and 33 ml (100 mg) and then discontinued). Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml (300mg hydrocortisone/ d) for maximum 3 days to prevent retardation of infarct healing.
干预措施: Vasopressin; Methylprednisolone; Hydrocortisone (Drug)
Control
Adrenaline alone arm (control)
- At randomization 1 ml sodium chloride 9 mg/ml (placebo) will be administered as soon as possible after adrenaline during the first five cycle of drug administration during CPR 1 ml sodium chloride 9 mg/ml (placebo) will be administered only during the first cycle of drug administration during CPR
b In the ICU sodium chloride 9 mg/ml (placebo) At 4 hours post ROSC, and then once daily, surviving patients with post-resuscitation shock will receive an infusion of 100 ml for ≤ 7 days. From day 8 post ROSC or when vasopressors are not needed the dos will be reduced daily to 67 ml and 33 ml and then discontinued. Patients with evidence of acute myocardial infarction will receive an infusion of 100 ml for 3 days.
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Survival at 30 days
时间窗: Survival at 30 days
Survival at 30 days
次要结局
未报告次要终点