Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Flow Mediated Vasodilation change
研究概览
简要总结
Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation alterations, specially in endothelial cell and its protective layer - glycocalyx. Endothelial dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is associated with bad prognosis.
High - dose corticoids administration at anesthesia induction in cardiac surgery could attenuate the intensity of this inflammatory reaction, and represents the current practice in our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery centres.
详细描述
Introduction Cardiac surgery is associated with variable severity organ dysfunction, which further leads to an increase of ICU length of stay (ICU LOS) or even higher mortality. Various mecanisms enter into account, from global through regional hemodynamics until microcirculation alterations.
These are due to an intense inflammatory reaction triggered by the contact of blood with cardiopulmonary bypass surfaces, the contact blood - air from cardiotomy aspiration, heparin and heparin - protamin complexes, ischemia - reperfusion mediators, and toxins from the digestive tube.
These alterations are observed in both the beating heart surgery and surgery with cardiopulmonary bypass (CBP). The inflammatory response is probably less important in off - pump surgery though this is hypothesis often questionned and some publications show that the changes associated with CBP could only be transient.
Inflammatory response is possibly reduced by high - dose corticoid administration at anesthesia induction - by preserving cell membrane integrity, leucocyte adhesion and cellular immunity attenuation, and finally by complement and cytokine release reduction.
Numerous metaanalyses show benefits of this strategy with an acceptable security profile:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •All patients eligible for cardiac surgery
排除标准
- •Age under 18years
- •Allergy to corticoids
- •Extreme emergency surgery
- •Upper member vascular disease
研究组 & 干预措施
Solu - Medrol
Solu - Medrol (methylprednisolone sodium succinate) 500mg IV once single administration
干预措施: Solu-medrol or placebo administration (Drug)
Placebo
NaCl 0,9% 100ml IV once single administration
干预措施: Solu-medrol or placebo administration (Drug)
结局指标
主要结局
Flow Mediated Vasodilation change
时间窗: 3 measurements of 5 minutes each - vascular occlusion test once daily during 48h.
Arterial diameter variation and Doppler flow are measured at brachial artery during vascular occlusion test - viariation of diameter and doppler flow befor and after cuff release will be assessed
次要结局
- StO2 variation change(4 measurements of 5 minutes each - vascular occlusion test test once daily during 48h)