European Registry for Hemadsorption of Septic Patients With the Seraph 100 Microbind Affinity Blood Filter (ASTREA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Although new techniques like extracorporeal blood purification have lately emerged, septic patients still have very high hospital mortality rates. Sepsis can be induced by either viremia, bacteriemia or in some cases both. Many studies have reported the effectiveness of different hemadsorbers, but patient sample sizes have been inadequate for definitive conclusions. Secondly, there are still no clear inclusion criteria as well as criteria for when to cease hemadsorption mostly due to immune dysregulation or cascade coagulation disorders. The aim of this observational prospective registry is to evaluate the effectiveness of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of septic ICU patients and to evaluate which cluster of these patients should benefit most with this therapy.
详细描述
Hemadsorption was introduced in everyday clinical practice before the COVID-19 pandemic. The efficacy of hemadsorption removal of endotoxins and cytokines is still, by some, controversial due to the fact that most of the studies were performed in a small number of patients with very different diagnoses, comorbidities and disease severity. Furthemore, some studies enrolled patients over a prolonged period of time with very high SOFA scores and multi-organ failure where it is difficult to expect any significant effect of any kind of organ support therapy. The COSA registry reported that the treatment of COVID-19 patients with Seraph 100 was well tolerated and observed lower mortality in the registry when compared to calculated mortality.
The primary aim of this observational prospective, multi-center, multistate web-based registry is to define the effectiveness and outcome of Seraph 100 treatment(s), investigate possible advantages of early targeted treatment and to set indications/inclusion criteria for the treatment of ICU septic patients with the method of hemoadsorption.
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
- •Sepsis or septic shock: sepsis is defined as the presence of suspected or documented infections along with systemic inflammatory response syndrome; septic shock is defined as the presence of sepsis and acute circulatory failure according to European criteria Society for Intensive Care Medicine
- •laboratory and clinical evidence of systemic inflammation: high levels of inflammatory cytokines such as IL-6 (>25 pg / ml); high values of inflammatory parameters from serum (leukocytes >15x10 9 / l, CRP >40 mg / l, procalcitonin >0.9 mg / l) and a high SOFA score (>2).
- •clinical symptoms of hemodynamic instability requiring vasopressors
- •diagnosis of ARDS
- •deterioration of respiratory status with the onset of respiratory failure requiring mechanical ventilation (respiration rate >30 / min, or oxygen saturation <93%, or PaO2 / FiO2 ratio <300mmHg).
- •Admission to ICU
排除标准
- •besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
结局指标
主要结局
Survival
时间窗: 28 days
Overall Survival after Seraph 100 therapy session
次要结局
- To assess the correlation between hemoperfusion and positive long-term outcome(28 days)
- The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome(72 hours after finishing the procedures with the combination of hemoperfusion and extracorporeal organ support therapies (i.e. ECMO, CRRT))
- The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome(28 days)
- To assess the correlation between hemoperfusion and negative short-term outcome(72 hours after finishing the hemoperfusion procedure)
- Length of ICU stay(28 days)
- Length of Hospital stay(60 days)
- Adverse events(28 days)
- Define the inclusion criteria for hemoperfusion with Seraph 100 in ICU septic patients(28 days)
- To assess the correlation between hemoperfusion and positive short-term outcome(72 hours after finishing the hemoperfusion procedure)
研究者
Vedran Premuzic
Principal Investigator
Croatian Society for Organ Support