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

NCT04351906 | Completed DMC

• 1 other identifier: AZ 63/20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

ARDS; Hypercapnic Respiratory Failure; AKI

Outcome Measures

Primary Outcomes (1)

• Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment

  Delta partial pressure of carbon dioxide change during ECCO2R treatment

  Up to 72 hours

Secondary Outcomes (7)

• Change in vasopressor use during ECCO2R

  Up to 72 hours

• Assessment of changes in tidal volume during ECCO2R

  Up to 72 hours

• Assessment of changes in pH during ECCO2R

  Up to 72 hours

• Assessment of changes in Positive End-Expiratory Pressure during ECCO2R

  Up to 72 hours

• Number of participants with adverse events directly related to ECCO2R

  Up to 72 hours

Study Arms (1)

ECCO2R

OTHER

ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis.

Device: ECCO2R

Interventions

ECCO2R DEVICE

ECCO2R integrated into the multiFiltrate device

ECCO2R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Giessen and Marburg, Giessen

Giessen, Hesse, 35382, Germany

Location

Related Publications (2)

• 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.

  PMID: 29743094 RESULT

• 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.

  PMID: 33304914 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Werner Seeger, MD

  University Hospital Giessen and Marburg, Giessen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ECCO2R

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 17, 2020
• Study Start: May 3, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

DE (1)