Acute Renal Failure, Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute Respiratory Distress syndrome, Acute renal Failure
Brief 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.
Interventions
DEVICECombined 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.
Sponsors
Hôpital Européen Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial carbon dioxide reduction | 20 min | 20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gas transfer measurement | 20 min, H1, H6, H12, H24, H36, H48 and H72. | Measurement of PO2 and PCO2 before and after the membrane oxygenation |
| Arterial blood gases | 20 min, H1, H6, H12, H24, H36, H48 and H72. | Measurement of arterial blood gases |
| carbon dioxide elimination (VCO2) | 20 min, H1, H6, H12, H24, H36, H48 and H72. | Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator |
| Respiratory mechanics and hemodynamic parameters | 20 min, H1, H6, H12, H24, H36, H48 and H72. | Measurement of respiratory mechanics and hemodynamic parameters |
| Safety monitoring | 20 min, H1, H6, H12, H24, H36, H48 and H72. | 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. |
Countries
France
Outcome results
None listed