SURgical Registry of Infective ENDocarditis in EuRope - SURRENDER
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Mortality at long-term follow-up
研究概览
简要总结
This is a prospective, multicentric, european registry of patients with infective endocarditis undergoing cardiac surgery. Patient demographics, clinical data and laboratory values will be collected, as well as treatment outcomes at day 30, day 90 and 1-5 years after the intervention.
详细描述
Infective endocarditis (IE) is now a relatively rare but worldwide disease (3-10 IE/100000 population/year) with increasing incidence especially in the Western world. IE is still associated with high morbidity and mortality, prolonged hospital stay, high risk of reinfection, significantly worsened prognosis for patients, substantially reduced quality of life, and in any case represents a major financial burden for the respective healthcare systems [1-11].
Patients who need to undergo cardiac surgery due to infective endocarditis (IE) are heterogeneous and present with a persistently high perioperative morbidity and mortality rate. Despite optimal and individualized perioperative management strategies, perioperative complications such as heart failure, systemic inflammatory response, vasoplegia, and sepsis is still the main reason for adverse outcomes following cardiac surgery.
The present European, multicenter IE registry (Surgical RegistRy of infective ENDocarditis in EuRope - SURRENDER) was initiated and established to record and appropriately analyze current surgical treatment options and perioperative adjunctive treatment strategies, as well as short- and long-term patient outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years
- •Written informed consent
排除标准
- •Age < 18 years
- •Missing declaration of consent
- •Current participation in another interventional trial
结局指标
主要结局
Mortality at long-term follow-up
时间窗: 1 to 5 years
at 1 to 5 years post-surgery
In-hospital mortality (all cause)
时间窗: 30 days or during index hospitalization
Overall mortality rate in-hospital, at day 30 or during index hospitalization
次要结局
- MACCE at long term follow-up(1 to 5 years)
- Sepsis accociated mortatilty(30 days or during index hospitalization)
- Vasoactive inotropic score(< 72h post-surgery)
- Mechanical ventilation time(30 days or during index hospitalization)
- Dialysis (RRT post-surgery)(30 days or during index hospitalization)
- Readmission due to IE recurrence(30 days to 1 year post-surgery)
- Post-operative sepsis(30 days or during index hospitalization)
- Renal failure(30 days or during index hospitalization)
- MACCE(30 days or during index hospitalization)
研究者
Matthias Thielmann
Prof. Dr. med.
University Hospital, Essen