The Effects of Enoximone in Acute Exacerbation COPD
- Conditions
- COPD ExacerbationEnoximonePhosphodiesterase Inhibitor
- Interventions
- Registration Number
- NCT04420455
- Lead Sponsor
- Rijnstate Hospital
- Brief Summary
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.
- Detailed Description
Ventilator will be set during the study period at Volume Controle, 6 ml/kg, 5 PEEP and a respiratory rate of 15 bpm with an I:E-ratio of 1:2.
Salbutamol/ipratropium bromide and magnesium sulphate will be administered at baseline (t=0h) and measurements will be made for an hour.
At T=1h the first dose of 0.5 mg/kg enoximone will be administered and will be repeated at T=2h and T=3h. Ventilator derived variables will be obtained every fifteen minutes and echocardiography, arterial and central venous bloodgas analyses every hour until t=6h.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- Patients with an AE-COPD for which intubation occurred within 24 hours before enrolment.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enoximone Enoximone Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.
- Primary Outcome Measures
Name Time Method PEEP within 6 hoursmeasured every 15 minutes Reduction in intrinsic PEEP, in cmH2O
- Secondary Outcome Measures
Name Time Method Airway resistence within 6 hours, measured every hour cmH2O/L/sec
VCO2 within 6 hours, measured every hour ml/min
etCO2 within 6 hours, measured every hour kPa
FiO2 within 6 hours, measured every hour percentage
Vd/Vt within 6 hours, measured every hour Measured by Bohr-equation, in percentage
Lung compliance within 6 hours, measured every hour ml/H2O
VEI within 6 hours, measured every hour ml
Shunt fraction within 6 hours, measured every hour measured by Fick-equation, using the SvO2, in percentage
Cardiac Output within 6 hours, measured every hour Measured by echocardiography (LVOT VTI), ml/hr
RVSP within 6 hours, measured every hour Measured by echocardiography, in mmHg
TAPSE within 6 hours, measured every hour Measured by echocardiography, in mm
MAPSE within 6 hours, measured every hour Measured by echocardiography, in mm
LV Ejection Fraction within 6 hours, measured every hour Measured by echocardiography, in percentage
Bloodgas analysis within 6 hours, measured every hour Arterial bloodgas analysis and central venous gas analysis (through catheter placed in superior vena cava)
Trial Locations
- Locations (1)
M.V. Koning
🇳🇱Arnhem, M, Netherlands