Extracorporeal CO2 Removal for Acute Decompensation of COPD

Summary

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide, resulting in a social and economic burden that is substantial and increasing. Exacerbations affect the prognosis and quality of life of patients with COPD. Hospital mortality of patients admitted for a hypercapnic exacerbation of COPD is approximately 10% and the long-term outcome is poor. In addition, hypercapnic exacerbation of COPD have serious negative impacts on patient quality of life, lung function and costs. Thus, prompt treatment of exacerbations may impact the clinical progression of COPD by ameliorating quality of life and prognosis.

Standard of care for patients with COPD exacerbation that need ICU admission for management of acute hypercapnic respiratory failure and severe respiratory acidosis is non-invasive ventilation (NIV). When NIV fails (arterial pH remains \< 7.30), invasive ventilation through endotracheal intubation is initiated to restore adequate gas-exchange. Extracorporeal circuits designed to remove CO2 (ECCO2R) may enhance the efficacy of NIV to remove CO2 and avoid the worsening of respiratory acidosis.

A recent matched cohort study with historical control, showed that: (a) the hazard of being intubated was three times higher in patients treated with "NIV-only" than in patients treated with "NIV-plus-ECCO2R"; (b) hospital mortality was significantly lower in "NIV plus ECCO2R" than in "NIV-only" \[8% (95% CI 1.0-26.0%) vs. 33% (95% CI 18.0-57.5%), respectively\]. However, ECCO2R-related complications were observed in almost half of the patients.

The consistency of the above discussed data, and the observation of the continuous increase use of ECCO2R despite the lack of solid evidence confirm that the equipoise regarding the use of ECCO2R may justify a randomized clinical trial to evaluate whether patients with respiratory acidosis refractory to NIV should be intubated and take the risks associated with invasive mechanical ventilation, or should be connected to ECCO2R to avoid intubation, but run the risk of the potentially serious ECCO2R-related complication The main objective of this randomized multicenter clinical trial is to test the hypothesis that in patients with acute life-threatening exacerbation of COPD, use of ECCO2R could increase event-free survival as compared to standard of care.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

ECCO2R

Extracorporeal CO2 Removal

DEVICE

NIV

Non-invasive ventilation

Sponsors & Collaborators

• University of Milan

  collaborator OTHER

• University of Turin, Italy

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• University of Bologna

  lead OTHER

Principal Investigators

• V. Marco Ranieri, M.D. · University of Bologna

• Stefano Nava, M.D. · University of Bologna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2024-08-01

Completion

2024-08-01