Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ARDS
- Sponsor
- University of Giessen
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
Time Frame: Up to 72 hours
Delta partial pressure of carbon dioxide change during ECCO2R treatment
Secondary Outcomes
- Rate of technical adverse events related to ECCO2R(Up to 72 hours)
- Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane(Up to 72 hours)
- Assessment of changes in tidal volume during ECCO2R(Up to 72 hours)
- Assessment of changes in pH during ECCO2R(Up to 72 hours)
- Assessment of changes in Positive End-Expiratory Pressure during ECCO2R(Up to 72 hours)
- Number of participants with adverse events directly related to ECCO2R(Up to 72 hours)
- Change in vasopressor use during ECCO2R(Up to 72 hours)