INFLACOR (INFLA-mmation A-fter C-ardiac O-pe-R-ation) - Use of Selected Genetic Variants, Cytokines, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 525
- 试验地点
- 1
- 主要终点
- Clinical phenotypes of inflammatory response: SIRS, acute lung injury/acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, perioperative myocardial infarct/injury, sepsis.
研究概览
简要总结
The aim of the study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of inflammatory response related complications in patients undergoing heart surgery with use of cardiopulmonary bypass.
详细描述
Identified so far predictors of mortality and/or morbidity in patients who undergo heart surgery with cardiopulmonary bypass (CPB), used in previous risk prediction models (EUROSCORE, CABDEAL, Cleveland), will be compared with new candidate variables:
- anamnestic: recent tooth extractions, chronic inflammatory diseases, specific drug use;
- biochemical: C-reacting protein, interleukin-6, tumor necrosing factor alpha;
- genetical: single nucleotide polymorphisms of 10 genes associated with inflammatory response; and
- clinical from the 1. postoperative day: systemic inflammatory response syndrome, APACHE-III score;
against their predictive capability of selected clinical phenotypes of inflammatory response occuring after surgery, beginning from day 2. after 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
- 是
入选标准
- •adults (age >=18)
- •given and signed informed consent
- •no previous cardiac surgery with opening the pericardium
排除标准
- •previous cardiac surgery with opening the pericardium
- •consent refused or not given
结局指标
主要结局
Clinical phenotypes of inflammatory response: SIRS, acute lung injury/acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, perioperative myocardial infarct/injury, sepsis.
时间窗: between day 2 after operation and hospital discharge
次要结局
- all cause inhospital mortality(from day 2 after operation)
研究者
Maciej M. Kowalik
Dr.
Medical University of Gdansk