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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01721434
Other study ID # Levo2
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received September 21, 2012
Last updated June 9, 2015
Start date September 2012
Est. completion date May 2016

Study information

Verified date June 2015
Source University Medical Center Nijmegen
Contact Leo MA Heunks, MD, PhD
Phone 024-3617273
Email l.heunks@ic.umcn.nl
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Levosimendan

Placebo
Similar coloured placebo

Locations

Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
University Medical Center Nijmegen Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Oxygen consumption (VO2) 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 No
Secondary 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 No
Secondary 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. No
Secondary 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 No
Secondary 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 No
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