Shorter Weaning From Invasive Ventilation With Levosimendan
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Mechanical Ventilation, Weaning Failure
In brief
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.
Key facts
- Study ID
- NCT07105202
- Run by
- Radboud University Medical Center
- People needed
- 250
- Starts
- 2025-09-17
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Treatment limitation decision in place: do not reintubate
- Previous treatment with levosimendan within 30 days.
- Currently in another interventional trial that might interact with study drug or primary outcome.
Where it is running
- Rijnstate Ziekenhuis Stichting — Arnhem, Gelderland, Netherlands (enrolling)
- Intensive Care Medicine, Radboud University — Nijmegen, Gelderland, Netherlands (enrolling)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Gelderland, Netherlands (enrolling)
- Jeroen Bosch Ziekenhuis Stichting — 's-Hertogenbosch, North Brabant, Netherlands (enrolling)
- Sint Franciscus Vlietland Groep Stichting — Rotterdam, South Holland, Netherlands (enrolling)
- Maasstad Ziekenhuis Stichting — Rotterdam, South Holland, Netherlands (enrolling)
- Catharina Ziekenhuis Stichting — Eindhoven, North Brabant, Netherlands
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) — Rotterdam, South Holland, Netherlands
Full record on ClinicalTrials.gov
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