Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome
Primary Purpose
ARDS, Hypercapnic Respiratory Failure, AKI
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ECCO2R
Sponsored by
About this trial
This is an interventional treatment trial for ARDS
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
Sites / Locations
- University Hospital Giessen and Marburg, GiessenRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ECCO2R
Arm Description
ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis.
Outcomes
Primary Outcome Measures
Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
Delta partial pressure of carbon dioxide change during ECCO2R treatment
Secondary Outcome Measures
Change in vasopressor use during ECCO2R
Epinephrine and norepinephrine dose, mcg/kg/min
Assessment of changes in tidal volume during ECCO2R
Assessment of changes in tidal volume
Assessment of changes in pH during ECCO2R
Assessment of changes in pH
Assessment of changes in Positive End-Expiratory Pressure during ECCO2R
Assessment of changes in Positive End-Expiratory Pressure
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.
Rate of technical adverse events related to ECCO2R
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
Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04351906
Brief Title
Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2020 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Giessen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Hypercapnic Respiratory Failure, AKI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
ECCO2R
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ECCO2R
Arm Type
Other
Arm Description
ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis.
Intervention Type
Device
Intervention Name(s)
ECCO2R
Intervention Description
ECCO2R integrated into the multiFiltrate device
Primary Outcome Measure Information:
Title
Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
Description
Delta partial pressure of carbon dioxide change during ECCO2R treatment
Time Frame
Up to 72 hours
Secondary Outcome Measure Information:
Title
Change in vasopressor use during ECCO2R
Description
Epinephrine and norepinephrine dose, mcg/kg/min
Time Frame
Up to 72 hours
Title
Assessment of changes in tidal volume during ECCO2R
Description
Assessment of changes in tidal volume
Time Frame
Up to 72 hours
Title
Assessment of changes in pH during ECCO2R
Description
Assessment of changes in pH
Time Frame
Up to 72 hours
Title
Assessment of changes in Positive End-Expiratory Pressure during ECCO2R
Description
Assessment of changes in Positive End-Expiratory Pressure
Time Frame
Up to 72 hours
Title
Number of participants with adverse events directly related to ECCO2R
Description
Adverse events directly related to ECCO2R are infection at the catheter site, hemorrhage at the cannulation site, air entry in the circuit.
Time Frame
Up to 72 hours
Title
Rate of technical adverse events related to ECCO2R
Description
Adverse events directly related to ECCO2R are clotting of the circuit.
Time Frame
Up to 72 hours
Title
Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane
Description
Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane
Time Frame
Up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faeq Husain-Syed, MD
Phone
+4964198542351
Email
faeq.husain-syed@innere.med.uni-giessen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Istvan Vadasz, MD
Phone
+4964198542351
Email
istvan.vadasz@innere.med.uni-giessen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Seeger, MD
Organizational Affiliation
University Hospital Giessen and Marburg, Giessen
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Giessen and Marburg, Giessen
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35382
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29743094
Citation
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.
Results Reference
result
PubMed Identifier
33304914
Citation
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.
Results Reference
derived
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Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome
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