Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome
- Conditions
- ARDSHypercapnic Respiratory FailureAKI
- Interventions
- Device: ECCO2R
- Registration Number
- NCT04351906
- Lead Sponsor
- University of Giessen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ECCO2R ECCO2R ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Assessment of changes in tidal volume during ECCO2R Up to 72 hours Assessment of changes in tidal volume
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
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
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.
Change in vasopressor use during ECCO2R Up to 72 hours Epinephrine and norepinephrine dose, mcg/kg/min
Trial Locations
- Locations (1)
University Hospital Giessen and Marburg, Giessen
🇩🇪Giessen, Hessen, Germany