Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Disability-free survival
研究概览
简要总结
In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, >90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.
详细描述
The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. Blood will be sampled prior to induction (Troponin), upon arrival in the intensive care unit (Troponin, HFABP and Copeptin), and on postoperative day 1 and 2 (Troponin). Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory.
All patients will be contacted after 30 days and 12 months by E-Mail, postal mail and/or phone call to obtain for the 12-item WHODAS 2 and information on potential events.
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
- •Adult (≥ 18 years of age)
- •Elective surgery
- •On-pump cardiac surgery (CABG and/or valvular surgery)
排除标准
- •Heart transplantation (HTX)
- •ACS at presentation (< 14 days)
- •Emergency surgery
- •Preoperative inotropic or mechanical circulatory support
- •Left or right ventricular assist device implantation
- •Unwilling or unable to provide consent
- •Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia
结局指标
主要结局
Disability-free survival
时间窗: 1 years after surgery
Disability is defined as a persistent (at least 6 months) impairment in health status, as measured by the 12-item WHODAS 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guidelines.
次要结局
- Days alive and out of hospital(At 30 days and 12 months after surgery)
- Length of ICU-stay(At 30 days)
- Major adverse cardiovascular events (MACE)(At 30 days and 12 months after surgery)
- All cause mortality(At 30 days and 12 months after surgery)
- Acute kidney injury (AKI)(At 30 days)