Prognostic Value of Copeptin Level Before Cardiac Surgery and Involvement in Systemic Inflammatory Response Syndrome After Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Preoperative copeptin level
研究概览
简要总结
The purpose of this study is to find a preoperative biomarker before cardiac surgery with cardiopulmonary bypass related to severe postoperative inflammatory response and circulatory complications. The investigators hypothesize that an increase of the preoperative stimulation of vasopressinergic system (in response to acute or chronic conditions) could lead to a microcirculatory dysfunction and favor the occurrence of vasodilatation during and after CPB and increase the symptoms of an inflammatory response after CPB. By defining a high risk population, a targeted strategy of monitoring and early or preventive treatment could improve postoperative prognosis.
详细描述
The occurrence of a severe systemic inflammatory response syndrome (SIRS) after elective cardiac surgery with cardiopulmonary bypass (CPB) is estimated at about 20% of cases and is characterized by hemodynamic changes (tachycardia, hypotension, hypovolemia). It is also responsible for vasodilation with impaired microcirculation involving increased morbidity and mortality associated with organ dysfunction and the risk of bacterial translocation. However, the participation of vasopressinergic system in the functional impairment of microcirculation is unclear.
Copeptin is considered a marker of vasopressin secretion, deriving from the same precursor, being more stable and easy to dose. In a previous study of 64 patients with CPB, the investigators have shown that high copeptin preoperative levels are associated with the occurrence of vasodilatation syndrome after cardiac surgery (incidence 15%) with a relative deficiency of postoperative vasopressin.
Microcirculatory alterations can be explored through the study of tissue oxygenation by NIRS (StO2) at rest and in response to a hypoxic challenge (provided by brief vascular occlusion). In septic shock, altered recovery slopes of tissue oxygenation are associated with poor prognosis. The investigators could find similar impact on prognosis in cardiogenic shock if first hours of care did not improve this recovery slope.
The investigators hypothesize that an increase of the preoperative stimulation of vasopressinergic system (in response to acute or chronic conditions) could favor the occurrence of vasodilatation during and after CPB and increase the symptoms of an inflammatory response after CPB. The involvement of vasopressin in microcirculatory dysfunction is unknown.
This is a validation study of a predictive test for pathophysiology and prognosis. This study will be monocentric, prospective and observational in routine care.
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 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery
- •Scheduled time of at least 24 hours
- •Cardiopulmonary bypass
排除标准
- •Urgent surgery within 24 hours of hospital admission
- •Chronic renal failure with preoperative glomerular filtration rate below 45 ml/min
- •Ongoing sepsis (ie uncontrolled endocarditis)
- •Immunosuppressive therapy (solid organ transplant recipient)
- •Previously included in this study
结局指标
主要结局
Preoperative copeptin level
时间窗: Preoperative 24 hours
Plasmatic copeptine will be measured from routine blood sample on heparinazed tubes. The biological assay will be performed by Time-Resolved Amplified Cryptate Emission on automate Kryptor Compact plus (ThermoFisher, Clichy, France). A level above the 97° percentile of referent population will be considered pathological.
次要结局
- Postoperative microcirculatory impairment(Within 2h of admission in intensive care unit, before weaning of sedation and mechanical ventilation)
- Occurrence of SIRS using classical definition(First postoperative 24 hours)
- Global organs dysfunction(First postoperative 24 hours)
- Intensive Care Unit stay(through study completion, an average of 3 month)
- Intensive Care Unit mortality rate(Up to 28 days)
- Perioperative copeptin kinetics(postoperative day)
- Renal replacement therapy(Up to 28 days)
- Postoperative hemodynamical impairment(First postoperative 24 hours)
- Lengh of mechanical ventilation(Up to 28 days)
- Acute kidney injury(Up to 28 days)
- Hospital stay(through study completion, an average of 3 month)
- Day 28 mortality rate(Up to 28 days)