COPD Exacerbation Clinical Trial
Official title:
The Effects of Enoximone in Acute Exacerbation COPD
Verified date | December 2021 |
Source | Rijnstate Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: The pharmacodynamic properties of enoximone could be beneficial for patients with an Acute Exacerbation COPD (AE-COPD). This research will focus on patients suffering of a severe AE-COPD and the bronchodilatory and inotropic effects of lower doses of enoximone. The main objective of the pilot study is to investigate if there is a bronchodilatory effect of enoximone in patients with AE-COPD. Secondary objective is to investigate a dose responsiveness in a range between 0.5 and 1.5 mg/kg enoximone. Methods: The study design is a prospective interventional non-randomized clinical series study involving patients admitted and intubated at the Intensive Care Unit (ICU) with an AE-COPD. Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. The primary objective is a reduction in auto-positive end-expiratory pressure (PEEP) after enoximone compared to baseline. A dose-titration will test for dose dependency. Secondary objectives are a reduction in ventilator pressures, a reduction in pulmonary artery pressures and an increase in cardiac output.
Status | Terminated |
Enrollment | 3 |
Est. completion date | December 21, 2021 |
Est. primary completion date | December 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with an AE-COPD for which intubation occurred within 24 hours before enrolment. Exclusion Criteria: - Patients with known asthma or interstitial lung disease (ILD) - Known neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Guillain-Barre and Dementia - Hypertrophic obstructive cardiomyopathy (HOCM) - Severe aortic stenosis with aortic valve area < 1cm2 - Known ventricular arrhythmias - Severe kidney disorders with Glomerular Filtration Rate (GFR) < 30 - Severe liver insufficiency with spontaneous PT/INR > 1.5 - Pregnancy - Lactation - High dose-diuretics use (daily dose of >480 mg furosemide) |
Country | Name | City | State |
---|---|---|---|
Netherlands | M.V. Koning | Arnhem | M |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PEEP | Reduction in intrinsic PEEP, in cmH2O | within 6 hoursmeasured every 15 minutes | |
Secondary | Lung compliance | ml/H2O | within 6 hours, measured every hour | |
Secondary | Airway resistence | cmH2O/L/sec | within 6 hours, measured every hour | |
Secondary | VEI | ml | within 6 hours, measured every hour | |
Secondary | VCO2 | ml/min | within 6 hours, measured every hour | |
Secondary | etCO2 | kPa | within 6 hours, measured every hour | |
Secondary | Vd/Vt | Measured by Bohr-equation, in percentage | within 6 hours, measured every hour | |
Secondary | FiO2 | percentage | within 6 hours, measured every hour | |
Secondary | Shunt fraction | measured by Fick-equation, using the SvO2, in percentage | within 6 hours, measured every hour | |
Secondary | Cardiac Output | Measured by echocardiography (LVOT VTI), ml/hr | within 6 hours, measured every hour | |
Secondary | RVSP | Measured by echocardiography, in mmHg | within 6 hours, measured every hour | |
Secondary | TAPSE | Measured by echocardiography, in mm | within 6 hours, measured every hour | |
Secondary | MAPSE | Measured by echocardiography, in mm | within 6 hours, measured every hour | |
Secondary | LV Ejection Fraction | Measured by echocardiography, in percentage | within 6 hours, measured every hour | |
Secondary | Bloodgas analysis | Arterial bloodgas analysis and central venous gas analysis (through catheter placed in superior vena cava) | within 6 hours, measured every hour |
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