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Completed

NCT Number: NCT04351906

Low-flow Extracorporeal Carbon Dioxide Removal 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Giessen and Marburg, Giessen

Giessen, Hesse, 35382, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECCO2R

Device

ECCO2R integrated into the multiFiltrate device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2020
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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