Effects of levosimendan on diaphragm function in mechanically ventilated patients

Phase 2

Completed

Conditions: 10028302
diaphragm dysfunction
respiratory muscle weakness

Registration Number: NL-OMON37368

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

• age >18 year
• mechanical ventilation for at least 3 days
• PaO2/FiO2 ratio >200 mmHg
• Ventilatory settings: Positive End Expiratory Pressure <=10 cmH2O, Pressure Support <= 10 cmH2O.

Exclusion Criteria

• pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases.
• pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
• upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
• phrenic nerve lesions
• pregnancy, breast feeding
• severe renal failure (serum creatinine > 450 µmol/L)
• severe hepatic failure
• recent (within 5 days) nasal bleeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the difference in neuro-mechanical efficiency of<br /><br>the diaphragm (i.e. the ratio of diaphragm electrical activity [Edi] and<br /><br>transdiaphragmatic pressure [Pdi]) before and after levosimendan administration<br /><br>during a CPAP trial.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Neuro-ventilatory efficiency of the diaphragm (i.e. the ratio of diaphragm<br /><br>electrical activity [Edi] and tidal volume [Vt]).<br /><br>• Oxygen consumption (VO2).<br /><br>• Carbon dioxide production (VCO2).<br /><br>• Oxygen level in blood (PaO2).<br /><br>• Carbon dioxide level in blood (PaCO2).<br /><br>• Accessory muscle recruitment (also in response to various pressure support<br /><br>level)<br /><br>i. electrical activity of the sternocleidomastoid muscle<br /><br>ii. electrical activity of the scalene muscles<br /><br>iii. electrical activity of the intercostal muscles<br /><br>iv. electrical activity of the genioglossal muscles</p><br>