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The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome
The prevalence of acute respiratory distress syndrome (ARDS) caused by COVID-19 is approximately 8%. Lung-protective ventilation is the current standard of care for ARDS. It limits lung and distal organ impairment, but is associated with hypercapnia in approximately 14% of patients with mild to moderate ARDS and almost all patients with severe ARDS. In this setting, early implementing of an extracorporeal CO2 removal (ECCO2R) therapy may prevent further escalation of invasiveness of therapy (eg, need for extracorporeal membrane oxygenation (ECMO)). A number of low-flow ECCO2R devices are now available and some of those can be integrated into a renal replacement therapy (RRT) platform. This study aims to investigate the efficacy of an original ECCO2R system used in conjunction with a RRT platform in hypercapnic patients with COVID-19-associated mild-to-moderate ARDS with or without acute kidney injury (AKI) necessitating RRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECCO2R | Other | ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECCO2R | Device | ECCO2R integrated into the multiFiltrate device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment | Delta partial pressure of carbon dioxide change during ECCO2R treatment | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vasopressor use during ECCO2R | Epinephrine and norepinephrine dose, mcg/kg/min | Up to 72 hours |
| Assessment of changes in tidal volume during ECCO2R | Assessment of changes in tidal volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Seeger, MD | University Hospital Giessen and Marburg, Giessen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Giessen and Marburg, Giessen | Giessen | Hesse | 35382 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29743094 | Result | Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5. | |
| 33304914 | Derived |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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ECCO2R
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| Up to 72 hours |
| Assessment of changes in pH during ECCO2R | Assessment of changes in pH | Up to 72 hours |
| Assessment of changes in Positive End-Expiratory Pressure during ECCO2R | Assessment of changes in Positive End-Expiratory Pressure | Up to 72 hours |
| Number of participants with adverse events directly related to ECCO2R | Adverse events directly related to ECCO2R are infection at the catheter site, hemorrhage at the cannulation site, air entry in the circuit. | Up to 72 hours |
| Rate of technical adverse events related to ECCO2R | Adverse events directly related to ECCO2R are clotting of the circuit. | Up to 72 hours |
| Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane | Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane | Up to 72 hours |
| Husain-Syed F, Birk HW, Wilhelm J, Ronco C, Ranieri VM, Karle B, Kuhnert S, Tello K, Hecker M, Morty RE, Herold S, Kehl O, Walmrath HD, Seeger W, Vadasz I. Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2020 Nov 12;7:598379. doi: 10.3389/fmed.2020.598379. eCollection 2020. |