Evaluating a CytoSorb Score in Septic Shock - a Retrospective Multicenter Data Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Hospital mortality
研究概览
简要总结
Systemic hyperinflammatory states, e.g. triggered by infection/sepsis, represent a major challenge for modern medicine. After an initially localized onset, inflammation can extend to an excessive, uncontrolled inflammatory reaction affecting the entire body and can trigger circulatory failure with subsequent irreversible multiple organ failure. Despite all the medical advances made in recent years, sepsis continues to be a substantial problem, as almost all therapeutic approaches have failed to prove their efficacy to date. Mortality in this clinical entity thus remains extremely high. In Germany alone, more than 100,000 people suffer from sepsis or septic shock every year, nearly half of whom die despite optimal therapy. Thus, sepsis is the third most common cause of death, has major importance both from a medical but also from an economical viewpoint, and approaches that could contribute to its successful treatment need to be further developed and explored.
If a patient experiences the spread of bacteria or their constituents in the blood stream due to an uncontrolled source of infection, the result is a deliberately triggered physiological defense reaction of the body. In many patients, however, there is a pathological dysregulation of these mechanisms, in a way that the defense reaction goes far beyond the physiological level required, resulting in an excessive immune response of the body, which is mainly facilitated by inflammatory mediators such as cytokines and chemokines. The immune response spreads throughout the body and also dissipates into organs unaffected by the original infection. In cases of such unwanted overshooting immune responses, an attempt to regain control of the described deleterious systemic events seems reasonable by removing the excess amount of cytokines from the blood, thus preventing or treating organ failure.
In this context, current therapeutic approaches increasingly focus on the elimination of inflammatory mediators.
In recent years, hemoadsorption, using a new adsorber (CytoSorb), has been used to treat sepsis and other conditions of hyperinflammation. The advantage of this therapeutic principle is that a wide range of inflammatory mediators are removed. In conjunction with the enormous elimination capacity, the effective and rapid reduction of mediators can be achieved.
To date, there have been more than 61,000 treatments using this procedure worldwide without device-related side effects being reported. The investigators have been treating patients with this procedure for over 5 years with consistently very favorable results. Therefore, the investigators would like to expand and deepen their observations with the proposed project.
详细描述
The primary effects of CytoSorb therapy, are, among many others, an improvement in hemodynamics, metobolism, and capillary integrity, with effects of adsorption seeming to reach far beyond mere cytokine adsorption.
Clinically, several publications have shown that certain patient populations benefit most from adjuvant CytoSorb treatment.
In a case series from the investigators department, they examined the effects of CytoSorb as an adjunctive therapy on hemodynamics and on clinically relevant outcome parameters in 26 patients with septic shock and the indication for renal replacement therapy. Treatment was associated with hemodynamic stabilization and reduction in blood lactate levels. The actual mortality was lower than predicted by APACHE II score. This effect was more pronounced in patients in whom therapy was initiated within 24 hours of sepsis diagnosis. Medical patients seemed to benefit more than post-surgical patients in terms of survival.
Based on these results, the investigators performed another study in seven patients with septic shock and ECMO (extracorporeal membrane oxygenation)-dependent acute respiratory distress syndrome (ARDS) treated with a combination therapy of CytoSorb, continuous renal replacement therapy (CRRT) and veno-venous ECMO. The combined treatment was associated with a significant stabilization in hemodynamics and a marked reduction in hyperlactatemia. In addition, patients also showed a significant improvement in lung function and invasiveness of ventilation, and the disease severity and organ dysfunction decreased significantly over the course of the combined treatment, while the observed mortality was only half that predicted by the APACHE II score. The investigators conclude that CytoSorb may be a potentially promising treatment option for patients with refractory ARDS under ECMO therapy in the context of septic shock.
Friesecke et al. prospectively investigated CytoSorb cytokine adsorption in combination with standard of care in 20 patients with refractory septic shock (defined as increasing vasopressor dosages to maintain a MAP of 65mmHg or increasing lactate levels despite protocol-based shock therapy over 6 hours). CytoSorb therapy was started on average after 7.8±3.7 hours of shock therapy. After initiating CytoSorb, norepinephrine dosages could be significantly reduced both after 6 (p=0.03) and 12 (p=0.001) hours. Lactate clearance also improved significantly. Reversal of septic shock was achieved in 13 (65%) patients, with a 28-day survival rate of 45% (with a SOFA predicted mortality of >80%). Treatment with CytoSorb resulted in shock reversal in 2/3 of these difficult-to-treat patients. Data from the CytoSorb registry also support these observations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •septic shock according Sepsis 3 criteria
排除标准
- •no data available, no icu treatment
结局指标
主要结局
Hospital mortality
时间窗: through study completion, an average of 49 days
次要结局
- Icu mortality(through study completion, an average of 49 days)
研究者
Klaus Kogelmann
Head of department, Prinipal investigator
Klinikum Emden