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

N/ACompletedNCT04351906

University of Giessen20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ARDS Hypercapnic Respiratory Failure AKI

Interventions

ECCO2RDEVICE

ECCO2R integrated into the multiFiltrate device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Giessen and Marburg, Giessen

Giessen, Hesse, Germany

Outcomes

Primary Outcomes

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

Delta partial pressure of carbon dioxide change during ECCO2R treatment

Time frame: Up to 72 hours

Secondary Outcomes

Change in vasopressor use during ECCO2R

Epinephrine and norepinephrine dose, mcg/kg/min

Time frame: Up to 72 hours

Assessment of changes in tidal volume during ECCO2R

Assessment of changes in tidal volume

Time frame: Up to 72 hours

Assessment of changes in pH during ECCO2R

Assessment of changes in pH

Time frame: Up to 72 hours

Assessment of changes in Positive End-Expiratory Pressure during ECCO2R

Assessment of changes in Positive End-Expiratory Pressure

Time frame: Up to 72 hours

Number of participants with adverse events directly related to ECCO2R

Adverse events directly related to ECCO2R are infection at the catheter site, hemorrhage at the cannulation site, air entry in the circuit.

Time frame: Up to 72 hours

Rate of technical adverse events related to ECCO2R

Adverse events directly related to ECCO2R are clotting of the circuit.

Time frame: Up to 72 hours

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

Data from ClinicalTrials.gov

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