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Shorter weaning from invasive ventilation with levosimendan: a randomized, double-blind, multicenter study in critically ill patients.
EU CTIS ID: 2024-518810-23-00
What this study is testing
The number of ventilator free days from randomization up until day 28.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Invasively ventilated for more than 48 hours.
- Failing at least one spontaneous breathing trial (SBT).
- Age above 18 years.
- Female patients of childbearing potential must have a negative pregnancy test (blood or urine) prior to participation
- Post-menopausal females (> 60 years of age or no menses for 12 consecutive months without an alternative medical cause with confirmatory follicle-stimulating hormone (FSH) level of ≥ 40mIU/mL) do not require contraception during the trial.
You likely can't join 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); pregnancy, breast feeding; known hypersensitivity to levosimendan.
- 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.
See the full eligibility criteria
- Invasively ventilated for more than 48 hours.
- Failing at least one spontaneous breathing trial (SBT).
- Age above 18 years.
- Female patients of childbearing potential must have a negative pregnancy test (blood or urine) prior to participation
- Post-menopausal females (> 60 years of age or no menses for 12 consecutive months without an alternative medical cause with confirmatory follicle-stimulating hormone (FSH) level of ≥ 40mIU/mL) do not require contraception during the trial.
- 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); pregnancy, breast feeding; known hypersensitivity to levosimendan.
- 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.
- Treatment with intermittent haemodialysis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.