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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04420455
Other study ID # 2019-1432
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 12, 2020
Est. completion date December 21, 2021

Study information

Verified date December 2021
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands M.V. Koning Arnhem M

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

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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