Clinical trial NCT04351906: Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Hypercapnic Respiratory Failure
AKI
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ECCO2R
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Change in vasopressor use during ECCO2R
timeFrame: Up to 72 hours
measure: Assessment of changes in tidal volume during ECCO2R
timeFrame: Up to 72 hours
measure: Assessment of changes in pH during ECCO2R
timeFrame: Up to 72 hours
measure: Assessment of changes in Positive End-Expiratory Pressure during ECCO2R
timeFrame: Up to 72 hours
measure: Number of participants with adverse events directly related to ECCO2R
timeFrame: Up to 72 hours
measure: Rate of technical adverse events related to ECCO2R
timeFrame: Up to 72 hours
measure: Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Hospital Giessen and Marburg, Giessen
state: Hessen
Study officials:
affiliation: University Hospital Giessen and Marburg, Giessen
name: Werner Seeger, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.