NCT00490828已完成4 期
Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- immunologic markers, health care related quality of life, PTSD
研究概览
简要总结
Hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory action. In this prospective interventional study this hypothesis is to be proven.
详细描述
Methods: Prospective interventional randomized double blind placebo controlled study.
Intervention: Hydrocortisone in stress doses vs. placebo
Patients: 92 high risk patients after cardiac surgery
Measurements: Cytokines, Toll-like receptors, NF kappa B, outcome data, health care related quality of life, PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min
排除标准
- •Pregnancy
- •Severe liver insufficiency
- •Severe renal insufficiency
- •Insulin dependent diabetes mellitus
- •Steroid therapy
- •Psychiatric disease
研究组 & 干预措施
A
Placebo Comparator
干预措施: Hydrocortisone (Drug)
B
Active Comparator
Stress doses of hydrocortisone
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
immunologic markers, health care related quality of life, PTSD
时间窗: one and a half year
次要结局
- early clinical outcome parameters (LOS in the ICU)(one year)
研究者
研究点 (1)
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