New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Composite primary outcome
研究概览
简要总结
The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date.
The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of
- Death
- Symptomatic embolism (systemic arterial embolism or pulmonary embolism)
- Bacteremia og pocket-infection
- Removal of a CIED due to new infection
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
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Culture positive or negative infection of a CIED acording to PI
- •Indication for removal of device
- •Clinical indication of device removal of existing device (concurrent left-sided IE is not a contraindication).
- •Indication for reimplantation of new device
- •A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered and/or culture negative antibiotic regimen have been adminstered until blood culture is examined.
- •stabilization criteria fulfilled i.e. I) negativ blood cultures, II) WBC < 15 mia/L or reduction of min. 25% and III) CRP <50 or min. 25% reduction.
排除标准
- •Immunoincompetence (active chemotherapy or prednisone treatment > 20mg/day
- •Device-infection within last 6 months (relaps)
- •Septic shock
- •Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment
研究组 & 干预措施
Immediate reimplantation
Reimplantation in same procedure as removal of device or shortly thereafter.
干预措施: Timing of reimplantation (Other)
Standart care
Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared
干预措施: Timing of reimplantation (Other)
结局指标
主要结局
Composite primary outcome
时间窗: within 6 months of randomization
Composite endpoint consisting of number of participants with one or more of the following events during follow-up: death, symptomatic embolism (systemic or pulmonary), bacteremia or pocket infection with same bacterial pathogen or removal of device due to new infection.
次要结局
未报告次要终点
研究者
Henning Bundgaard
Professor
Rigshospitalet, Denmark