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

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

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

Study Overview

• Status: Recruiting
• Conditions: AKI; ARDS; Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: ECCO2R

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faeq Husain-Syed, MD; Phone Number: +4964198542351; Email: faeq.husain-syed@innere.med.uni-giessen.de
• Study Contact Backup: Name: Istvan Vadasz, MD; Phone Number: +4964198542351; Email: istvan.vadasz@innere.med.uni-giessen.de

Study Locations

• Germany
  • Hessen
    • Giessen, Hessen, Germany, 35382
      • Recruiting
      • University Hospital Giessen and Marburg, Giessen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ECCO2R; ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis.	Device: ECCO2R; ECCO2R integrated into the multiFiltrate device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Study Director: Werner Seeger, MD, University Hospital Giessen and Marburg, Giessen

Publications and helpful links

General Publications

• 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. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.
• Husain-Syed F, Birk HW, Wilhelm J, Ronco C, Ranieri VM, Karle B, Kuhnert S, Tello K, Hecker M, Morty RE, Herold S, Kehl O, Walmrath HD, Seeger W, Vadasz I. Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2020 Nov 12;7:598379. doi: 10.3389/fmed.2020.598379. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2020
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: AZ 63/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No