Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Arterial carbon dioxide reduction
研究概览
简要总结
In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.
Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.
The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.
For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Acute Respiratory Distress Syndrome according to the AECC definition
- •Acute Renal Failure according to the RIFLE definition
排除标准
- •Age < 18 years
- •PaO2/FiO2 < 100 with FIO2 = 1 and PEEP > 18 cmH2O
- •DNR order or death expected within the next 3 days
- •Intracranial haemorrhage or hypertension
- •Heparin allergy
结局指标
主要结局
Arterial carbon dioxide reduction
时间窗: 20 min
20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
次要结局
- Gas transfer measurement(20 min, H1, H6, H12, H24, H36, H48 and H72.)
- Safety monitoring(20 min, H1, H6, H12, H24, H36, H48 and H72.)
- Arterial blood gases(20 min, H1, H6, H12, H24, H36, H48 and H72.)
- carbon dioxide elimination (VCO2)(20 min, H1, H6, H12, H24, H36, H48 and H72.)
- Respiratory mechanics and hemodynamic parameters(20 min, H1, H6, H12, H24, H36, H48 and H72.)
研究者
Jerome Allardet-Servent, MD
MD, MSc
Hôpital Européen Marseille
