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

Sponsor
University of Giessen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04351906
Collaborator
(none)
20
1
1
25.9
0.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: ECCO2R
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
ECCO2RECCO2R
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
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment [Up to 72 hours]

    Delta partial pressure of carbon dioxide change during ECCO2R treatment

Secondary Outcome Measures

  1. Change in vasopressor use during ECCO2R [Up to 72 hours]

    Epinephrine and norepinephrine dose, mcg/kg/min

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

    Assessment of changes in tidal volume

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

    Assessment of changes in pH

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

    Assessment of changes in Positive End-Expiratory Pressure

  5. Number of participants with adverse events directly related to ECCO2R [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 [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 [Up to 72 hours]

    Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Giessen and Marburg, Giessen Giessen Hessen Germany 35382

Sponsors and Collaborators

  • University of Giessen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Giessen
ClinicalTrials.gov Identifier:
NCT04351906
Other Study ID Numbers:
  • AZ 63/20
First Posted:
Apr 17, 2020
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021