Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients

This study is currently recruiting participants.
Verified November 2012 by University Medical Center Nijmegen
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Leo Heunks, University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01721434
First received: September 21, 2012
Last updated: November 1, 2012
Last verified: November 2012

September 21, 2012
November 1, 2012
September 2012
December 2013   (final data collection date for primary outcome measure)
Neuro-mechanical efficiency of the diaphragm [ Time Frame: Artefact-free periode in the last 10 minutes of each CPAP trial ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01721434 on ClinicalTrials.gov Archive Site
  • Neuro-ventilatory efficiency of the diaphragm [ Time Frame: Artefact-free periode in the last 10 minutes of each CPAP trial ] [ Designated as safety issue: No ]
    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.
  • Oxygen consumption (VO2) [ Time Frame: Artefact-free periode in the last 10 minutes of each CPAP trial ] [ Designated as safety issue: No ]
    A secondary outcome measure is the oxygen consumption during a continuous positive airway pressure (CPAP) trial.
  • Partial pressure of oxygen in arterial blood (PaO2) [ Time Frame: Last minute of the 30 minute CPAP trial ] [ Designated as safety issue: No ]
    A secondary outcome measure is the PaO2 at the end of a continuous positive airway pressure (CPAP) trial.
  • Accessory respiratory muscle activity [ Time Frame: Measured during a one hour protocol after the second CPAP trial. ] [ Designated as safety issue: No ]
    To determine the effects of levosimendan on accessory respiratory muscle function, ventilator settings are adapted after the last CPAP-trial.
  • Carbon dioxide production (VCO2) [ Time Frame: Artefact-free periode in the last 10 minutes of each CPAP trial ] [ Designated as safety issue: No ]
    A secondary outcome measure is the carbon dioxide production during a continuous positive airway pressure (CPAP) trial.
  • Partial pressure of carbon dioxide in arterial blood (PaCO2) [ Time Frame: Last minute of the 30 minute CPAP trial ] [ Designated as safety issue: No ]
    A secondary outcome measure is the PaCO2 at the and of a continuous positive airway pressure (CPAP) trial.
Same as current
Not Provided
Not Provided
 
Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients
Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Muscle Weakness Conditions
  • Weaning Failure
  • Drug: Levosimendan
    Other Name: Simdax
  • Drug: Placebo
    Similar coloured placebo
  • Experimental: Levosimendan
    Levosimendan 0.2 ug/kg/min intravenous for a single 7 hours.
    Intervention: Drug: Levosimendan
  • Placebo Comparator: Placebo
    Similar coloured placebo intravenous for a single 7 hours
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • mechanical ventilation > 3 days
  • informed consent
  • able to sustain a CPAP trial for 30 minutes
  • 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 known 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 > 150 umol/L)
  • severe hepatic failure
  • recent (within 5 days) nasal bleeding
  • systolic blood pressure < 120 mmHg
Both
18 Years and older
No
Contact: Leo MA Heunks, MD, PhD 024-3617273 l.heunks@ic.umcn.nl
Contact: Jonne Doorduin, MSc 024-3617273 j.doorduin@ic.umcn.nl
Netherlands
 
NCT01721434
Levo2
No
Leo Heunks, University Medical Center Nijmegen
University Medical Center Nijmegen
Orion Corporation, Orion Pharma
Principal Investigator: Leo Heunks, MD, PhD Radboud University
University Medical Center Nijmegen
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP