Levosimendan is a relatively new drug that improves cardiac contractility in patients with heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial contractile proteins. Recent data from our lab showed that levosimendan improves contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of disorders associated with impaired respiratory muscle function, such as mechanically ventilated patients.We hypothesize that levosimendan could improve respiratory muscle function in mechanically ventilated patients commencing a CPAP trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
Similar coloured placebo
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
RECRUITINGNeuro-mechanical efficiency of the diaphragm
The primary outcome measure is the neuro-mechanical efficiency(i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm during a continuous positive airway pressure (CPAP) trial.
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
Neuro-ventilatory efficiency of the diaphragm
A secondary outcome measure is the neuro-ventilatory efficiency (i.e. the ratio of diaphragm electrical activity and tidal volume) during a continuous positive airway pressure (CPAP) trial.
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
Oxygen consumption (VO2)
A secondary outcome measure is the oxygen consumption during a continuous positive airway pressure (CPAP) trial.
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
Partial pressure of oxygen in arterial blood (PaO2)
A secondary outcome measure is the PaO2 at the end of a continuous positive airway pressure (CPAP) trial.
Time frame: Last minute of the 30 minute CPAP trial
Accessory respiratory muscle activity
To determine the effects of levosimendan on accessory respiratory muscle function, ventilator settings are adapted after the last CPAP-trial.
Time frame: Measured during a one hour protocol after the second CPAP trial.
Carbon dioxide production (VCO2)
A secondary outcome measure is the carbon dioxide production during a continuous positive airway pressure (CPAP) trial.
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
Partial pressure of carbon dioxide in arterial blood (PaCO2)
A secondary outcome measure is the PaCO2 at the and of a continuous positive airway pressure (CPAP) trial.
Time frame: Last minute of the 30 minute CPAP trial
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