Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
研究概览
简要总结
The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome
详细描述
The prevalence of acute respiratory distress syndrome (ARDS) caused by COVID-19 is approximately 8%. Lung-protective ventilation is the current standard of care for ARDS. It limits lung and distal organ impairment, but is associated with hypercapnia in approximately 14% of patients with mild to moderate ARDS and almost all patients with severe ARDS. In this setting, early implementing of an extracorporeal CO2 removal (ECCO2R) therapy may prevent further escalation of invasiveness of therapy (eg, need for extracorporeal membrane oxygenation (ECMO)). A number of low-flow ECCO2R devices are now available and some of those can be integrated into a renal replacement therapy (RRT) platform. This study aims to investigate the efficacy of an original ECCO2R system used in conjunction with a RRT platform in hypercapnic patients with COVID-19-associated mild-to-moderate ARDS with or without acute kidney injury (AKI) necessitating RRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •mild-to-moderate ARDS according to the Berlin definition
- •lung-protective ventilation with positive end-expiratory pressure (PEEP) > 5 cm of water on mechanical ventilation expected to last > 24 h
- •hypercapnia <80 mmHg
- •bilateral opacities on chest imaging
排除标准
- •age < 18 years
- •pregnancy
- •patients with decompensated heart failure or acute coronary syndrome
- •respiratory acidosis with persistent partial pressure of blood carbon dioxide (PCO2) levels >80 mmHg
- •acute brain injury
- •severe liver insufficiency (Child-Pugh scores > 7) or fulminant hepatic failure
- •decision to limit therapeutic interventions
- •catheter access to femoral vein or jugular vein impossible
- •pneumothorax
结局指标
主要结局
Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
时间窗: Up to 72 hours
Delta partial pressure of carbon dioxide change during ECCO2R treatment
次要结局
- Rate of technical adverse events related to ECCO2R(Up to 72 hours)
- Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane(Up to 72 hours)
- Assessment of changes in tidal volume during ECCO2R(Up to 72 hours)
- Assessment of changes in pH during ECCO2R(Up to 72 hours)
- Assessment of changes in Positive End-Expiratory Pressure during ECCO2R(Up to 72 hours)
- Number of participants with adverse events directly related to ECCO2R(Up to 72 hours)
- Change in vasopressor use during ECCO2R(Up to 72 hours)