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临床试验/NCT01239966
NCT01239966已完成3 期

Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure

Hôpital Européen Marseille4 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2010年11月1日最近更新:
适应症

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

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

发起方
Hôpital Européen Marseille
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerome Allardet-Servent, MD

MD, MSc

Hôpital Européen Marseille

研究点 (4)

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