Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT07105202
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07105202
Study Brief:
Protocol Section:
NCT07105202