Shorter Weaning From Invasive Ventilation With Levosimendan

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called levosimendan can help patients who have trouble coming off a breathing machine (ventilator) in the intensive care unit (ICU). Sometimes, patients need help breathing with a machine for a long time, and it can be hard to stop this support because the muscles used for breathing, especially the diaphragm, become weak. Levosimendan is a drug that helps muscles work better without making the body use more oxygen, and researchers want to see if it can improve diaphragm strength and help patients breathe on their own sooner than usual.

To join the trial, patients need to be adults who have been on a ventilator for more than two days and have already tried but failed at least one test to breathe without the machine. Women under 60 will need a pregnancy test before joining. Some people won’t be able to take part, such as those with certain muscle or brain conditions, severe kidney or liver problems, or those currently in other conflicting studies. If accepted, participants will receive either levosimendan or a placebo (a treatment with no active drug) while doctors watch closely to see if their breathing improves faster. This study is not yet recruiting, but it hopes to find a new way to help patients get off ventilators more quickly and safely.

Gender

ALL

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.