Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 433
- 试验地点
- 1
- 主要终点
- Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium
研究概览
简要总结
This is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11~2023.05. From this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. These two cohorts were compared to evaluate the effect of preoperative iron deficiency on patient outcomes.
The primary end point was the occurrence of composite morbidity/mortality end points which were: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. Occurrence of any one of these outcomes counted as primary end point met. Secondary outcome was to evaluate and compare hemoglobin recovery of iron replete and deficient patients until one year after surgery.
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
- 29 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received off pump coronary artery bypass surgery (OPCAB) between 2016.11.01-2023.05.31
排除标准
- •preoperative anemia (male Hb <13g/dL, female Hb<12g/dL)
- •emergency surgery
- •redo-off pump coronary artery bypass surgery
- •minimally invasive coronary artery bypass surgery
- •OPCAB in conjunction with other cardiac surgical procedures (e.g. valve surgery, graft replacement surgery of the aorta)
- •intraoperative on pump conversion
- •lack of sufficient preoperative data (ferritin, transferrin saturation, C-reactive protein) to determine iron status
- •administration of intravenous iron within 4 weeks or parenteral iron of more than 2 weeks prior to surgery
- •enrollemnt in other clinical studies
结局指标
主要结局
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium
时间窗: from the end of surgery until patient discharge (assessed up to day 60)
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Number of participants with acute kidney injury
时间窗: until 7 days after surgery
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Number of participants with post operative myocardial infarction
时间窗: until 48 hours post-surgery
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
次要结局
- Post discharge hemoglobin(Until 1 year after surgery)