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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined ECCOR and RRT | Device | Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme Allardet-Servent, MD | Hopital Ambroise Pare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Paul Desbief | Marseille | 13002 | France | |||
| Hopital Ambroise Pare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17038660 | Background | Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12. | |
| 19741487 |
| Label | URL |
|---|---|
| information related to hospitals and investigators involved | View source |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. |
| Marseille |
| 13006 |
| France |
| Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2. |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |