跳至主要内容
临床试验/NCT04292249
NCT04292249已完成不适用

Predictive Value of suPAR and hsCRP on Postoperative Mortality in 951 Patients Undergoing Elective On-pump Cardiac Surgery

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 951 人开始时间: 2012年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
951
试验地点
1
主要终点
Association of preoperative suPAR values in relation to the censored time-to-event outcome "death from any cause"

研究概览

简要总结

This study aims to investigate whether preoperative soluble urokinase plasminogen activating receptor (suPAR) and High-sensitivity C-Reactive Protein (hsCRP) are independent markers of death after cardiac surgery. Further, to assess whether suPAR and hsCRP provides increased predictive accuracy of the clinical risk model EuroSCORE II. The purpose of the study is to gain knowledge on whether these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represents a significant risk in patients undergoing cardiovascular surgery. Hence, these biomarkers may assist clinicians in selecting compassionate treatment for high risk patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Planned elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), single and multiple valvular procedures, combined CABG and valvular surgery, and others)
  • Given informed consent on delivering a blood sample for the biobank.

排除标准

  • Peroperatively cancelling the surgery
  • Sudden change to off-pump coronary artery bypass (OPCAB) surgery
  • Death prior to surgery
  • Project blood samples not available.

结局指标

主要结局

Association of preoperative suPAR values in relation to the censored time-to-event outcome "death from any cause"

时间窗: from index surgery to censoring date 12.31.2018

次要结局

  • Association of preoperative hsCRP values in relation to the censored time-to-event outcome "death from any cause"(from index surgery to censoring date 12.31.2018)
  • Assess whether adding suPAR, hsCRP or combined suPAR+hsCRP measurements improves predictive accuracy of EuroSCORE II(from index surgery to 30 days postoperative)
  • Sensitivity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome "death from any cause"(from index surgery to 30 days postoperative)
  • Specificity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome "death from any cause"(from index surgery to 30 days postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Roed Rasmussen

Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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