Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis - a Multicentric Randomized Controlled Group Sequential Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 28
- 主要终点
- SOFA Score
研究概览
简要总结
Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.
详细描述
The investigators assume a common standard deviation of 3.8 points and that a 1.4-point lower SOFA score in the Intervention Group is of clinical relevance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participant will not be informed about group allocation
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
- •patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
- •informed consent
- •age ≥18 years
排除标准
- •EuroScoreII ≤ 3
- •current participation in another interventional Trial
- •pregnancy
- •current immunosuppressive or immunomodulatory therapy (with dosing of glucocorticoids over Cushing threshold)
- •previous participation in the REMOVE study
结局指标
主要结局
SOFA Score
时间窗: 24 hours before until day 9 post-surgery
The investigators will test if mean SOFA scores are different for the experimental and control group.
次要结局
- Days on ventilator, vasopressor and renal replacement therapy(until day 30 post-surgery)
- Overall mortality rate(until day 30 post surgery)
- SOFA subscores(24 hours before surgery until day 9 post-surgery)
- length of ICU and in-hospital stay(until day 30 post-surgery)
- Changes in cytokine and cfDNA levels(24 hours before, during cardiac surgery and 24 hours after surgery)
- incidence of stroke(until day 30 post-surgery)