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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan | Experimental | Levosimendan 0.2 ug/kg/min intravenous for a single 7 hours. |
|
| Placebo | Placebo Comparator | Similar coloured placebo intravenous for a single 7 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Neuro-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. | Artefact-free periode in the last 10 minutes of each CPAP trial |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Artefact-free periode in the last 10 minutes of each CPAP trial |
| Oxygen consumption (VO2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leo MA Heunks, MD, PhD | Contact | 024-3617273 | l.heunks@ic.umcn.nl | |
| Jonne Doorduin, MSc | Contact | 024-3617273 | j.doorduin@ic.umcn.nl |
| Name | Affiliation | Role |
|---|---|---|
| Leo Heunks, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Recruiting | Nijmegen | Gelderland | 6500HB | Netherlands |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
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| Drug |
Similar coloured placebo |
|
A secondary outcome measure is the oxygen consumption during a continuous positive airway pressure (CPAP) trial. |
| 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. | 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. | 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. | 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. | Last minute of the 30 minute CPAP trial |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |