Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Impact of plasma exchange
研究概览
简要总结
Plasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (FFP: 1/3) in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.
详细描述
Plasma exchange (PE) is a standardized and safe therapeutic procedure, used in the treatment of various diseases that require rapid and prolonged elimination of endogenous and exogenous substances, with deleterious effects on the function of different organs and systems. The efficacy and safety of PE has been demonstrated in patients with fulminant hepatitis (FH), an entity characterized by an exacerbated inflammatory response, multi-organ failure, and high short-term mortality. In FH, plasma exchange improves systemic inflammation, prevents organ failure and renal support requirements, and improves survival. Such treatment eliminates important endogenous and exogenous inducers of the systemic inflammatory response (PAMPs and DAMPs), proinflammatory mediators (cytokines and ROS), and other biologically active substances (nitric oxide, prostaglandins, and bradykinin) that are involved in the pathogenesis of organ failure. Several case reports also suggest that PE is an effective rescue therapy in critically ill patients with influenza A (H1N1). However, the efficacy of PE has not been evaluated in critically ill patients with COVID-19 disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject ≥18 years and < 80 years of age;
- •Subjects with diagnosis of COVID-19 disease by PCR in nasopharyngeal smear, sputum, or bronchial aspirates;
- •Subjects admitted in ICU with invasive mechanical ventilation;
- •Informed consent granted via telephone by relatives or legal representative
排除标准
- •More than seven days with invasive mechanical ventilation
- •Refractory Shock (Noradrenaline dose > 0.5 micrograms/ kg/minute)
- •Decompensated Cirrhosis
- •Chronic kidney disease requiring hemodialysis
- •Active neoplastic disease
- •Severe chronic heart failure (NYHA class III or IV)
- •Severe pulmonary disease (GOLD III or IV)
- •HIV infection (AIDS criteria)
研究组 & 干预措施
Plasma exchange
Plasma exchange with human serum albumin + Polyclonal immunoglobulin + standard medical treatment
干预措施: Plasma exchange (Biological)
Standar medical treatment
Standar medical treatment
干预措施: Standar medical treatmen (Drug)
结局指标
主要结局
Impact of plasma exchange
时间窗: 28 days
Number of exitus at 28 days after plasma exchange in patients with COVID-19 disease and invasive mechanical ventilation.
次要结局
未报告次要终点
研究者
Anna Cruceta
Project Manager
Fundacion Clinic per a la Recerca Biomédica