The Effects of Enoximone in Acute Exacerbation COPD

NCT ID: NCT04420455

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-12
• Study Completion Date: 2021-12-21

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.

Conditions

COPD Exacerbation; Enoximone; Phosphodiesterase Inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enoximone

Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.

Group Type: EXPERIMENTAL

Enoximone

Intervention Type: DRUG

Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.

Interventions

Enoximone

Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

M.V. Koning

Arnhem, M, Netherlands

Countries

Netherlands

Other Identifiers

2019-1432

Identifier Type: -

Identifier Source: org_study_id