Shorter Weaning From Invasive Ventilation With Levosimendan
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
Prolonged weaning from mechanical ventilation is a common and serious challenge in the ICU, associated with increased morbidity, mortality, and length of stay. Diaphragm dysfunction plays a key role in weaning failure, and current strategies to support respiratory muscle function are limited. Levosimendan is a calcium sensitizer that enhances cardiac and skeletal muscle contractility, including the diaphragm, without increasing oxygen demand.
The investigators hypothesize that treatment with Levosimendan in difficult-to-wean ICU patients will improve diaphragm function and thereby shorten the duration of mechanical ventilation compared to placebo.
Eligibility criteria
Qualifiers
Invasively ventilated > 48 hours.
Failed at least one spontaneous breathing trial (SBT).
Age above 18 years.
Female patients with age < 60 must have a negative pregnancy test (blood or urine) prior to participation.
Disqualifiers
Pre-existing neuromuscular disease (congenital or acquired)
Endotracheally intubated primarily for neurological reason (e.g., traumatic brain injury, intracranial haemorrhage, epilepsy, intracranial infection), or developed severe intracranial haemorrhage/infarction during ICU stay.
Contra-indications for levosimendan: severe renal failure (creatinine clearance <30mL/min) unless managed with appropriate continuous kidney replacement therapy (such as CRRT), severe liver failure (Child-Pugh class C), history of torsade des pointes; known significant mechanical obstructions affecting ventricular filling/ outflow or both; prolonged QTc interval (QTc > 470ms); breast feeding; known hypersensitivity to levosimendan.
Treatment with intermittent haemodialysis.
Trial design
Treatments tested in this trial
- levosimendan
- Soluvit
- Standard care
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov