The Effects of Enoximone in Acute Exacerbation COPD

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rijnstate Hospital
• Treatments: Enoximone

Criteria

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)