NCT00773058Unknown4 期
Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency
Southeast University, China0 个研究点目标入组 100 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Evidence of clinically definite ARDS confirmed by AECC criteria in 1994
研究概览
简要总结
The purpose of this study is to see if stress doses of hydrocortisone improve early outcome in patients who are in early stage of ARDS and with relative adrenal insufficiency.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •within the first 3 days of onset of clinically definite ARDS confirmed by AECC criteria in 1994
- •18 to 85 year old
排除标准
- •pregnancy or lactation
- •tumor or other immunologic disease
- •immunosuppressive drug used
- •bone marrow or lung transplantation
- •primary or secondary disease of adrenal gland
- •hormone used within 3 months
- •refusing conventional therapy
- •be in other clinical tests within 30 days
研究组 & 干预措施
glucocorticoid+RAI
Active Comparator
stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI
干预措施: hydrocortisone (Drug)
placebo + RAI
Placebo Comparator
no glucocorticoid But ATCH test hints RAI
干预措施: placebo (Drug)
glucocorticoid
Active Comparator
stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI
干预措施: hydrocortisone (Drug)
placebo
Placebo Comparator
no glucocorticoid But ATCH test does not hint RAI
干预措施: placebo (Drug)
结局指标
主要结局
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994
时间窗: within the first 3 days after surgery onset of ARDS
次要结局
未报告次要终点
研究者
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