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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-03

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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ARDS Hypercapnic Respiratory Failure AKI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

ECCO2R

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECCO2R

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

Group Type OTHER

ECCO2R

Intervention Type DEVICE

ECCO2R integrated into the multiFiltrate device

Interventions

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ECCO2R

ECCO2R integrated into the multiFiltrate device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No