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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351906
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
University of Giessen

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

Condition or disease Intervention/treatment Phase
ARDS Hypercapnic Respiratory Failure AKI Device: ECCO2R Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: ECCO2R
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 3, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : October 1, 2021


Arm Intervention/treatment
ECCO2R
ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis.
Device: ECCO2R
ECCO2R integrated into the multiFiltrate device




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in vasopressor use during ECCO2R [ Time Frame: Up to 72 hours ]
    Epinephrine and norepinephrine dose, mcg/kg/min

  2. Assessment of changes in tidal volume during ECCO2R [ Time Frame: Up to 72 hours ]
    Assessment of changes in tidal volume

  3. Assessment of changes in pH during ECCO2R [ Time Frame: Up to 72 hours ]
    Assessment of changes in pH

  4. Assessment of changes in Positive End-Expiratory Pressure during ECCO2R [ Time Frame: Up to 72 hours ]
    Assessment of changes in Positive End-Expiratory Pressure

  5. 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.

  6. 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.

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351906


Contacts
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Contact: Faeq Husain-Syed, MD +4964198542351 faeq.husain-syed@innere.med.uni-giessen.de
Contact: Istvan Vadasz, MD +4964198542351 istvan.vadasz@innere.med.uni-giessen.de

Locations
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Germany
University Hospital Giessen and Marburg, Giessen Recruiting
Giessen, Hessen, Germany, 35382
Sponsors and Collaborators
University of Giessen
Investigators
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Study Director: Werner Seeger, MD University Hospital Giessen and Marburg, Giessen
Publications of Results:
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Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT04351906    
Other Study ID Numbers: AZ 63/20
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury