NCT01239966

Pulmonary And Renal Support During Acute Respiratory Distress Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Hôpital Européen Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Respiratory Distress Syndrome
• Acute Renal Failure

Interventions

Type	Name	Description
DEVICE	Combined ECCOR and RRT	Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2010-11-15
• Last updated: 2016-02-23

Locations

2 sites across 1 country: France