ARDS, Hypercapnic Respiratory Failure, AKI
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEECCO2R
ECCO2R integrated into the multiFiltrate device
Sponsors
University of Giessen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
ECCO2R
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mild-to-moderate ARDS according to the Berlin definition * lung-protective ventilation with positive end-expiratory pressure (PEEP) \> 5 cm of water on mechanical ventilation expected to last \> 24 h * hypercapnia \<80 mmHg * bilateral opacities on chest imaging
Exclusion criteria
* age \< 18 years * pregnancy * patients with decompensated heart failure or acute coronary syndrome * respiratory acidosis with persistent partial pressure of blood carbon dioxide (PCO2) levels \>80 mmHg * acute brain injury * severe liver insufficiency (Child-Pugh scores \> 7) or fulminant hepatic failure * decision to limit therapeutic interventions * catheter access to femoral vein or jugular vein impossible * pneumothorax
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment | Up to 72 hours | Delta partial pressure of carbon dioxide change during ECCO2R treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of changes in tidal volume during ECCO2R | Up to 72 hours | Assessment of changes in tidal volume |
| Assessment of changes in pH during ECCO2R | Up to 72 hours | Assessment of changes in pH |
| Assessment of changes in Positive End-Expiratory Pressure during ECCO2R | Up to 72 hours | Assessment of changes in Positive End-Expiratory Pressure |
| Change in vasopressor use during ECCO2R | Up to 72 hours | Epinephrine and norepinephrine dose, mcg/kg/min |
| Rate of technical adverse events related to ECCO2R | Up to 72 hours | Adverse events directly related to ECCO2R are clotting of the circuit. |
| Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane | Up to 72 hours | Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane |
| Number of participants with adverse events directly related to ECCO2R | Up to 72 hours | Adverse events directly related to ECCO2R are infection at the catheter site, hemorrhage at the cannulation site, air entry in the circuit. |
Countries
Germany
Outcome results
None listed