NCT07105202 Shorter Weaning From Invasive Ventilation With Levosimendan
| NCT ID | NCT07105202 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Radboud University Medical Center |
| Condition | Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2025-09-17 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07105202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07105202 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07105202 currently recruiting?
Yes, NCT07105202 is actively recruiting participants. Contact the research team at esther.deleijer@radboudumc.nl for enrollment information.
Where is the NCT07105202 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Nijmegen, Netherlands, Nijmegen, Netherlands, 's-Hertogenbosch, Netherlands and 4 additional locations.
Who is sponsoring the NCT07105202 clinical trial?
NCT07105202 is sponsored by Radboud University Medical Center. The trial plans to enroll 250 participants.