Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome

Conditions
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AKI, ARDS, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: ECCO2R


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: ECCO2R
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ECCO2R<br>ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis. | Device: ECCO2R<br>* ECCO2R integrated into the multiFiltrate device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |