Pulmonary And Renal Support During Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Respiratory Distress Syndrome, Acute Renal Failure

Intervention / Treatment
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* Device: Combined ECCOR and RRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Respiratory Distress Syndrome according to the AECC definition Acute Renal Failure according to the RIFLE definition Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial carbon dioxide reduction | 20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT | 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas transfer measurement | Measurement of PO2 and PCO2 before and after the membrane oxygenation | 20 min, H1, H6, H12, H24, H36, H48 and H72. | 
| Arterial blood gases | Measurement of arterial blood gases | 20 min, H1, H6, H12, H24, H36, H48 and H72. | 
| carbon dioxide elimination (VCO2) | Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator | 20 min, H1, H6, H12, H24, H36, H48 and H72. | 
| Respiratory mechanics and hemodynamic parameters | Measurement of respiratory mechanics and hemodynamic parameters | 20 min, H1, H6, H12, H24, H36, H48 and H72. | 
| Safety monitoring | Continuous measurement of the differential pressure across the oxygenator membrane and across the hemofilter. Assessment of catheter dysfunction, clotting or disruption of the extra-corporeal circuit, clotting of the oxygenator membrane or of the hemofilter. Assessment of patient's haemorragic or thrombotic complications. | 20 min, H1, H6, H12, H24, H36, H48 and H72. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Distress syndrome, Acute renal Failure