Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Identifying risk factors for peri-operative complications in patients who have had COVID-19
研究概览
简要总结
A. Primary objective
Identifying risk factors for peri-operative complications in patients who have had COVID-19.
B. Secondary objectives
Identifying peri-operative complications in patients who have had COVID-19. Follow-up of peri-operative complications during hospitalization. Identifying the safe distance at which a patient can be operated after a Sars CoV2 infection without having an increased risk of peri-operative complications.
C. Study inclusion and exclusion criteria
- Inclusion criteria
Patients should be included if:
- are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
- they give their consent for their data to be included in studies;
- Exclusion criteria
Patients should be excluded if:
- they have emergency surgery;
- have had Sars Cov 2 infection more recently than 3 months;
D. Data Collection
It is done in an excel table. Data collection is done anonymously. No patient-identifying data will be collected. The collected data will be about comorbidities, COVID-19 status - disease and vaccination, postoperative complications.
详细描述
Types of data collection from the patients:
The type of surgery Age Sex Smoking Diabetes History of renal disease Preoperative anemia Preoperative creatinine Preoperative urea BMI NYHA class ASA score EuroScore I Preoperative LVEF Disease COVID -19 Date of illness Hospitalization for COVID-19 COVID 19 vaccination status Necessary vasopressor peri-operative duration and Maximum dose Perioperative positive inotrope required Bypass duration Duration of Aortic clamping Intraoperative transfusions Post operative creatinine - peak level Post-operative urea peak level Duration of post-operative oro-tracheal intubation NIV required Duration of hospitalization in Cardiac Intensive Care Unit Duration of postoperative hospitalization
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
- •they give their consent for their data to be included in studies;
排除标准
- •they have emergency surgery;
- •have had Sars Cov 2 infection more recently than 3 months;
结局指标
主要结局
Identifying risk factors for peri-operative complications in patients who have had COVID-19
时间窗: 3 years
次要结局
- Identifying peri-operative complications in patients who have had COVID-19(3 years)
- Identifying the safe distance at which a patient can be operated after a Sars CoV2 infection without having an increased risk of peri-operative complications.(3 years)
研究者
Cornelia Elena Predoi
phD student
Carol Davila University of Medicine and Pharmacy