Changes in Microvascular Perfusion During Blood Purification With Cytosorb® in Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- improvement in perfused vessel density
研究概览
简要总结
Sepsis is defined as a life-threatening event due to a dysregulated immune response to an host. Blood purification techniques may be considered as a therapeutic weapon to front sepsis and septic shock.
Haemoadsorption is one of the known blood purification technique that is employed in this study, and it is based on the principle that whole blood, contacting the surface of proper designed sorbent, would be cleared of certain substrates. With haemoadsorption it is possible to de-circulate from bloodstream high molecular weight substances, such as cytokines.In this study Cytosorb® cartridge, based on haemoadsorption principle is applied on septic patients, suffering for acute kidney failure, along with continuous veno-venous haemodialysis (CVVH-D).Microcirculation has a crucial role in the natural history of sepsis.
In this prospective observational non interventional study, 10 septic patients with an acute kidney failure that need CVVH are enrolled.
The primary endpoint of the study is to verify an improvement in the density of microcirculatory vessels and in the quality of blood flow after exposure to Cytosorb®. These two parameters are well described synthetically by the Perfused Vessel Density (PVD).
As secondary endpoints we also want to analyze the modification of microcirculation after haemoadsorption therapy: microvascular blood flow, described by the microvascular flow index (MFI) and peripheral tissue oxygen perfusion during Cytosorb® exposure using near infrared spectroscopy technique (NIRS)
详细描述
Introduction Sepsis is defined as a life-threatening event due to a dysregulated immune response to an infection. Blood purification techniques may be considered as a therapeutic weapon to front sepsis and septic shock.
The rationale of blood purification in sepsis is to modulate a dysregulated profile of immune response to the host in order to reduce tissue damage due to over production of pleiotropic pro-inflammatory cytokines.
Blood purification may also control elevated levels of anti-inflammatory cytokines that may lead to a down-modulation of immune system and immunoparalysis.
Haemoadsorption is one of the known blood purification technique that is employed in this study, and it is based on the principle that whole blood, contacting the surface of proper designed sorbent, would be cleared of certain substrates. With haemoadsorption it is possible to de-circulate from bloodstream high molecular weight substances, such as cytokines.
In this study Cytosorb® cartridge, based on haemoadsorption principle is applied on septic patients, suffering for acute kidney failure, along with continuous veno-venous haemodialysis (CVVH-D).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •septic patients with acute kidney failure that need to undergo CHHV treatment.
排除标准
- •hypersensitivity or allergy to the components of the cartridge
- •pregnancy
- •maxillary-facial trauma that prohibits mouth access and sublingual microcirculation evaluation.
结局指标
主要结局
improvement in perfused vessel density
时间窗: 24 hours
improvement in perfusion of the sublingual microcirculation
次要结局
- improvement in microvascular flow index(6 hours and 24 hours)
- improvement in tissue oxygenation(6 hours and 24 hours)
- improvement in perfused vessel density(6 hours)
研究者
Abele Donati, MD
Professor
Università Politecnica delle Marche