Combined ECCOR and RRT
DeviceInsertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.
NCT Number: NCT01239966
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Hopital Ambroise Pare, Marseille, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.
Time frame: 20 min
20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Measurement of PO2 and PCO2 before and after the membrane oxygenation
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Measurement of arterial blood gases
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator
Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Measurement of respiratory mechanics and hemodynamic parameters
Time frame: 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.
Hôpital Européen Marseille
Other
Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure
Acronym: PARSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04316884
Acute Kidney Injury, Acute Respiratory Distress Syndrome
Uppsala, Uppsala County, Sweden
View Trial DetailsNCT04402957
Acute Kidney Injury, Acute Respiratory Distress Syndrome
San Diego, California, United States
View Trial DetailsNCT04286490
Acute Kidney Injury, Acute Respiratory Distress Syndrome
Grenoble, France
View Trial DetailsNCT04154007
Acute Kidney Injury, Acute Respiratory Distress Syndrome
Zagazig, Sharqia Province, Egypt
View Trial Details