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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04351906
• Other study ID #: AZ 63/20
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Giessen
• Contact: Faeq Husain-Syed, MD
• Phone: +4964198542351
• Email: faeq.husain-syed[@]innere.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• AKI
• ARDS
• Hypercapnic Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Device:
• ECCO2R
ECCO2R integrated into the multiFiltrate device

Locations

Country	Name	City	State
Germany	University Hospital Giessen and Marburg, Giessen	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in vasopressor use during ECCO2R	Epinephrine and norepinephrine dose, mcg/kg/min	Up to 72 hours
Secondary	Assessment of changes in tidal volume during ECCO2R	Assessment of changes in tidal volume	Up to 72 hours
Secondary	Assessment of changes in pH during ECCO2R	Assessment of changes in pH	Up to 72 hours
Secondary	Assessment of changes in Positive End-Expiratory Pressure during ECCO2R	Assessment of changes in Positive End-Expiratory Pressure	Up to 72 hours
Secondary	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
Secondary	Rate of technical adverse events related to ECCO2R	Adverse events directly related to ECCO2R are clotting of the circuit.	Up to 72 hours
Secondary	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