NCT00676585已完成1 期
Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to Shock Reversal
研究概览
简要总结
The major goal of this project is to determine whether the use of physiologic doses of corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and alters microcirculatory flow in post-cardiac arrest patients.
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
- •Greater than 18 years old
- •Either pre-hospital cardiac arrest and ROSC or Inpatient Cardiac Arrest with resultant ROSC
- •Vasopressor dependent for a minimum of 1 hour post-arrest
排除标准
- •Indication for Corticosteroids outside of current research proposal
- •DNR or comfort care measures
- •Presence of septic shock
- •Chronic Use (>1week) of oral Corticosteroids in the last year
研究组 & 干预措施
2
Placebo Comparator
Normal Saline
干预措施: Normal Saline (Drug)
1
Experimental
Hydrocortisone 100mg every 8 hours.
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Time to Shock Reversal
时间窗: 7 Days
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
次要结局
- Mortality(Length of hospital stay, an average of 9 days with a maximum of 36 days)
- Sub-group Analysis of Patients With Adrenal Insufficiency(At time of enrollment)
研究者
Michael Donnino
Michael Donnino, MD
Beth Israel Deaconess Medical Center
研究点 (1)
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