Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Muscle Weakness Conditions Weaning Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levosimendan

Levosimendan 0.2 ug/kg/min intravenous for a single 7 hours.

Group Type EXPERIMENTAL

Levosimendan

Intervention Type DRUG

Placebo

Similar coloured placebo intravenous for a single 7 hours

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Similar coloured placebo

Interventions

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Levosimendan

Intervention Type DRUG

Placebo

Similar coloured placebo

Intervention Type DRUG

Other Intervention Names

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Simdax

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No