Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percentage of patients with corrected hypercapnia
研究概览
简要总结
Pulmonary vascular dysfunction (DVP) is associated with a pejorative prognosis during ARDS. There is no specific therapeutic intervention to thwart it. Extracorporeal CO2 purification (ECCO2-R) is a technique that has been very rapidly diffused and adopted in intensive care since commercialization of the devices but, the formal clinical evaluation is insufficient. It could significantly improve the prognosis of patients with both DVP and refractory hypercapnia.
详细描述
This is a prospective, non-comparative, open-label, multicenter regional study, without random drawing or blindfolding.
The primary objective of the study is the correction by ECCO2-R of hypercapnia in patients with DVP in moderate to severe ARDS under protective ventilation.
The primary endpoint is the percentage of patients with hypercapnia correction (defined as a 20% decrease in PaCO2 at H2 of ECCO2-R initiation).
The secondary objectives are:
- Demonstrate that ECCO2-R allows in hypercapnic ARDS and DVP patients to correct hypercapnia with H6 and H24, improve DVP and hemodynamics, reduce alveolar dead space, improvement of respiratory mechanics
- Assess the tolerance of the evaluated technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Moderate to severe ARDS according to the Berlin definition;
- •Pulmonary vascular dysfunction at echocardiography (pulmonary arterial hypertension, right ventricular dilatation or dyskinesia of the interventricular septum);
- •Refractory hypercapnia, defined by a PaCO2 ≥48 mmHg in spite of the reduction of the instrumental dead space and the increase of the respiratory rate.
- •Free and informed written consent for persons in a position to consent; consent of the support person/parent/relative in case of incapacity to consent; inclusion in emergency situations (Article L1122-1-2 of the CSP)
排除标准
- •Age <18 years;
- •Known pregnancy or breastfeeding;
- •Contra-indication to curative anticoagulation, thrombocytopenia <50 G / L, heparin-induced thrombocytopenia, known hypersensitivity to heparin or to compounds;
- •Femoral or jugular venous access impossible;
- •Refractory hypoxemia with indication at ECMO;
- •No affiliation to social security or beneficiary
研究组 & 干预措施
Extracorporeal CO2 removal
Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)
干预措施: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) (Device)
结局指标
主要结局
Percentage of patients with corrected hypercapnia
时间窗: at hour 2 (H2)
20% decrease in PaCO2 two hours after ECCO2-R initiation
次要结局
- Relative change of capnia at H6 and H24 after ECCO2-R(at hour 6 (H6), at hour 24 (H24))
- Changes in hemodynamic parameters(H2, H6, H24)
- Changes in alveolar deadspace(H2, H6, H24)
- Number of complications related to ECCO2-R technique(ICU Discharge or day 28)
- Proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24(H6, H24)
- Changes in respiratory mechanics(H2, H6, H24)
- Changes in echocardiographic indices(H2, H6, H24)
- Percentage of mortality(ICU discharge or day 28)