Immunophenotyping of Patients Undergoing Open Heart Surgery to Assess Their Susceptibility of Developing a Systemic Inflammatory Response Syndrome (SIRS)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with SIRS as assessed by SOFA-Score
研究概览
简要总结
The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.
详细描述
The study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. The samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. The diagnosis of SIRS will be made during routine clinical visits on the first seven postoperative days using the Sepsis-related Organ Failure Assessment score (SOFA-score). The patients will be followed up for 30 days.
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
- •Age > 18 years
- •Informed consent of the patient
- •Patient undergoing a open heart surgery using a cardiopulmonary bypass
排除标准
- •Age < 18 years
- •Missing informed consent
- •Renal failure
- •Liver failure
- •Neurodegenerative disease
- •Malignancies
- •Immune therapy
结局指标
主要结局
Number of participants with SIRS as assessed by SOFA-Score
时间窗: 30 days
The study investigates the relationship between the intra-individual inflammatory patterns in patients with uncomplicated (no SIRS) and complicated postoperative courses (SIRS) after open heart surgery. The diagnosis of SIRS will be made by using the Sepsis-related Organ Failure Assessment score (SOFA-score). Patients with an increase in SOFA-score \>3 are considered to have SIRS.
次要结局
- Number of participants with postoperative delir as assessed by CAM-ICU(30 days)
- Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels(30 days)
- Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification)(30 days)
- Number of participants with infection as assessed by microbiological, serological and radiological examination(30 days)
- Number of participants with new atrial fibrillation as assessed by ECG(30 days)
- Length of stay in ICU(30 days)
- In-hospital mortality(30 days)
- Length of stay in hospital(30 days)
研究者
Dr. Christian Bode
Principal Investigator
University of Bonn