Shorter Weaning From Invasive Ventilation With Levosimendan
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
| Condition(s) | Mechanical Ventilation, Weaning Failure |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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. Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Radboud University Medical Center |
| Locations | Arnhem, Gelderland, Netherlands; Nijmegen, Gelderland, Netherlands; Nijmegen, Gelderland, Netherlands; 's-Hertogenbosch, North Brabant, Netherlands; Eindhoven, North Brabant, Netherlands; Rotterdam, South Holland, Netherlands (+2 more sites) |
| Start date | 2025-09-17 |
| NCT ID | NCT07105202 |
| Official listing | https://clinicaltrials.gov/study/NCT07105202 |