- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351906
Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome
November 30, 2023 updated by: University of Giessen
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
Hessen
-
Giessen, Hessen, Germany, 35382
- Recruiting
- University Hospital Giessen and Marburg, Giessen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ECCO2R
ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis.
|
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
Time Frame: Up to 72 hours
|
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
Time Frame: Up to 72 hours
|
Epinephrine and norepinephrine dose, mcg/kg/min
|
Up to 72 hours
|
Assessment of changes in tidal volume during ECCO2R
Time Frame: Up to 72 hours
|
Assessment of changes in tidal volume
|
Up to 72 hours
|
Assessment of changes in pH during ECCO2R
Time Frame: Up to 72 hours
|
Assessment of changes in pH
|
Up to 72 hours
|
Assessment of changes in Positive End-Expiratory Pressure during ECCO2R
Time Frame: Up to 72 hours
|
Assessment of changes in Positive End-Expiratory Pressure
|
Up to 72 hours
|
Number of participants with adverse events directly related to ECCO2R
Time Frame: 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.
|
Up to 72 hours
|
Rate of technical adverse events related to ECCO2R
Time Frame: Up to 72 hours
|
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
Time Frame: Up to 72 hours
|
Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane
|
Up to 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Werner Seeger, MD, University Hospital Giessen and Marburg, Giessen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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