Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic ; International Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively.
研究概览
简要总结
This study will describe the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will focus on hemodynamic failure and organ dysfunction after surgery.
Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.
This investigator-led, non-commercial, non-interventional does not collect any patient identifiable information.
详细描述
Performing cardiac surgery in the context of SARS-CoV2 infection is potentially at risk of marked post-operative hemodynamic failure (shock) due to the inflammatory reaction generated by the surgery and the extracorporeal circulation associated with the viral infection. In addition, in the absence of infection, 30-50% of patients will experience acute post-operative respiratory failure due to the combined effects of extracorporeal circulation and general anesthesia. The pulmonary tropism of the virus therefore is susceptible to increase in post-operative respiratory impairment.
Thus, the infection is likely to favor the occurrence of post-operative shock but also to aggravate respiratory failure and other post-operative organ failures.
Therefore, the investigators designed an observational study that aims at comparing two groups of patients:
- Cardiac or thoracic surgery patients with a negative Covid-19 PCR pre-operatively and in the 15 following days
- Cardiac or thoracic surgery patients with a positive Covid-19 PCR in the 15 days before surgery
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
- •Adults (age ≥18 years) undergoing cardiac or thoracic surgery
- •With positive PCR in the 5 days before or after cardiac/thoracic surgery.
排除标准
- 未提供
结局指标
主要结局
Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively.
时间窗: 12 hours post-operatively
The VIS score correlates with mortality after cardiac surgery and reflects the degree of patient hemodynamic failure. This score is calculated as follows: ISR = Dobutamine dose in g/kg/min + 100 times the Adrenaline dose in g/kg/min + 100 times the Noradrenaline dose in g/kg/min + 10,000 times the Vasopressin dose in U/kg/min.
次要结局
- Post-operative organ failure(5 days post-operatively)
- Post-operative outcome(28 days post-operatively)