Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery - a Prospective Non-interventional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Composite of cardiovascular complications
研究概览
简要总结
Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is still unknown. Therefore, we will evaluate as our primary aim the association between patients with increased postoperative inflammation, assessed with C-reactive protein measurements, and the occurrence of major cardiovascular complications after noncardiac surgery. We will further evaluate the influence of perioperative inflammation on the occurrence of postoperative acute kidney injury. We will also evaluate the association between inflammation and the influence on Days-At-Home within 30 days. Furthermore, we will evaluate the association between increased inflammatory biomarkers and postoperative N-terminal pro brain natriuretic peptide (NT-proBNP) concentration.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NT-proBNP ≥ 200 ng/L
- •Troponin T > 25 ng/L
- •History of coronary artery disease
- •History of peripheral artery disease (PAD)
- •75 years or older
- •History of transient ischemic attack (TIA) or stroke
- •Current smoking or cessation of smoking within 2 years
- •Diabetes or currently taking anti-diabetic drug
- •Hyperlipidemia
- •History of hypertension or currently taking an antihypertensive drug
- •Atrial fibrillation
排除标准
- •Patients on immune-suppressive therapy
- •ICU patients undergoing surgery
- •Preoperative Sepsis/systemic inflammatory syndrome (SIRS) needing ICU treatment
- •Preoperative hemodynamically instable patients, who require vasopressor or inotropic support
- •History of severe heart failure (defined as left ventricular ejection fraction (LVEF) < 30%)
- •Liver cirrhosis
- •Chronic inflammatory bowel diseases (CIBD)
- •Severe rheumatic diseases requiring immunosuppressive treatment
结局指标
主要结局
Composite of cardiovascular complications
时间窗: within 30 days after surgery and one year after surgery
The primary aim of the study is to investigate the influence of the maximum C-reactive protein value (over the first 3 days after surgery) on the incidence of major cardiovascular complications within 30 days after surgery. The composite binary endpoint is defined as myocardial infarction, myocardial injury after noncardiac surgery, new onset of atrial fibrillation, stroke or death.
次要结局
- Acute Kidney Injury - Procalcitonin(within 5 days after surgery)
- Interleukin 6(within 30 days after surgery)
- Acute Kidney Injury - C-reactive proteint(within 5 days after surgery)
- C-reactive protein(within 30 days after surgery)
- Acute Kidney Injury - Interleukin 6(within 5 days after surgery)
- Procalcitonin(within 30 days after surgery)
- Acute Kidney Injury - Copeptin(within 5 days after surgery)
- Days at home within 30 days (DAH 30)(within 30 days after surgery)
- NT-proBNP(within 5 days after surgery)
- Copeptin(within 30 days after surgery)
研究者
Christian Reiterer
PD Dr. med. univ.
Medical University of Vienna