South-Eastern Europe Registry for Hemoperfusion of Covid-19 ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Define the inclusion criteria for hemoperfusion in ICU COVID-19 patients
研究概览
简要总结
The ongoing COVID-19 pandemic caused high hospitalization and mortality rates especially in critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. The purpose of this registry study is to investigate the effectiveness and safety of the extracorporeal blood purification and hemoperfusion/hemadsorption filters in treating of critically ill COVID-19 patients.
详细描述
The COVID-19 pandemic has been associated with high mortality rate and high percentage of patients with with severe multi-organ dysfunction. Many therapies were investigated in this group of patients. The usage of extracorporeal blood purification, namely hemoperfusion/hemadsorption was introduced in everyday clinical practice even before COVID-19 pandemic in which became increasingly common. The efficacy of hemoperfusion/hemadsorption in removal of endotoxins and cytokines is still questioned by some physicians mostly due to the fact that some trials failed to demonstrate the effect of this therapy on long-term outcomes of critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. Several extracorporeal blood purification therapies have been proposed to attenuate systemic inflammation in COVID-19 patients but there is no study which analyzed more than one filter or patients without specific conditions. Due to these limitations the studies were not able to analyze the method itself. Therefore, the primary aim of this observational prospective, multi-centric, regional web-based registry is to define the results and outcome of treatment, possible advantages over patients who have not undergone targeted treatment and to set regional indications/inclusion criteria for the treatment of ICU COVID-19 patients with the method of hemoadsorption/hemoperfusion.
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
- •COVID-19 infection
- •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).
- •diagnosed with 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
- •clinical symptoms of hemodynamic instability requiring vasopressors and initial signs immune dysregulation or cascade coagulation disorders
- •acute kidney injury assessed according to KDIGO / AKIN criteria: increase in serum creatinine ≥ 0.3 mg / dL within 48 hours, or ≥ 50% over 7 days, or hourly diuresis <0.5 mL / kg / h for more than 6 hours
- •diagnosis of ARDS
- •the need for ECMO
- •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
Define the inclusion criteria for hemoperfusion in ICU COVID-19 patients
时间窗: 28 days
Define the inclusion criteria for extracorporeal blood purification (hemoperfusion) with different filters/hemadsorbers in ICU COVID-19 patients
次要结局
- To assess the correlation between hemoperfusion and positive short-term outcome(72 hours after finishing all the hemoperfusion procedures)
- To assess the correlation between hemoperfusion and positive long-term outcome(28 days)
- To assess the correlation between different filters/hemadsorbers and positive short-term outcome(72 hours after finishing all the hemoperfusion procedures)
- To assess the correlation between different filters/hemadsorbers and positive long-term outcome(28 days)
- The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome(28 days)
- The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome(72 hours after finishing all the procedures with the combination of filters/hemadsorbers and extracorporeal organ support therapy)
研究者
Vedran Premuzic
Principal Investigator
Croatian Society for Organ Support