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Terminated NCT05546606

CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases

Conditions: COPD Acute Exacerbation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 17
Sponsor: Assistance Publique - Hôpitaux de Paris

Location: CHU Angers Angers

Summary

The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Very severe AE of COPD will be defined by high risk of Non-Invasive Ventilation (NIV) failure defined by need of intubation and/or in-Intensive Care Unit (ICU) mortality (Stratum 1) or by Invasive Mechanical Ventilation (IMV) after NIV failure and/or with severe hyperinflation and hypercapnia (Stratum 2).

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years * Known or suspected diagnosis of COPD based on clinical history, pulmonary function test when available, arterial blood gases, physical examination, and chest radiograph * Worsening dyspnea for \< 2 weeks * Written informed consent signed by patients or their surrogates, with possibility of an emergency procedure with deferred consent * Patient affiliated to a Social Security System (excluding "AME: aide médicale d'état") * Negative serum or urinary β-hCG for women of child-bearing potential * Very severe AE criteria defined either by: 1. Stratum 1: high likelihood of NIV failure defined by PaCO2 \> 55 mmHg and pH \< 7.25, either at baseline and/or after at least one hour of NIV 2. Stratum 2: intubation and IMV since less than 72 hrs, either after NIV failure and/or with pH \< 7.30 and PaCO2 \> 55 mmHg and PEEPi (end-expiratory occlusion) \> 5 cmH2O, while on Assist-Controlled Ventilation with the following parameters: VT: 8 ml/kg, RR: 12/min., applied PEEP: 0 cmH2O Exclusion Criteria: * Hemodynamic instability * Known allergy to heparin or to any of the excipients of the specialty used * Contra-indications to heparin listed in the SmPC of the specialty used. * History of type II Heparin-induced thrombocytopenia * Thrombocytopenia (platelets \< 100.000/mm3) * Recent major surgery * Haemorrhagic disorders such as: * Organic lesion likely to bleed * Bleeding manifestations or tendencies linked to disorders of hemostasis * Intracerebral hemorrhage * Uncontrolled arrhythmia * Bleeding diathesis * Body Mass Index \> 35 kg/m2 * PaO2/FiO2 \< 180 mmHg * Do not intubate order * Fibrosing idiopathic interstitial pneumonitis (based on the available medical files) * Neuromuscular diseases (based on the available medical files) * Patients with tracheotomy * Patients with severe concomitant chronic systemic disease with a limited probability of survival (\< 6 months) * Severely disabled (confinement to bed and inability to wash or dress alone) patients before AE * Pregnant woman * Participation in another interventional study involving human participants up to their ICU discharge, whether the studies include an investigational medical device, or being in the exclusion period at the end of a previous study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05546606). StuddyBuddy aggregates publicly available trial information.