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New treatment option for Mechanical Ventilation
Official title Shorter Weaning From Invasive Ventilation With Levosimendan
ClinicalTrials.gov ID: NCT07105202
What this study is testing
What is levosimendan?
levosimendan is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for mechanical ventilation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
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...
- Contra-indications for levosimendan: severe renal failure (creatinine clearance \ 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.
See the full eligibility 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.
- 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...
- Contra-indications for levosimendan: severe renal failure (creatinine clearance \ 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 treatment trial that might interact with study drug or primary outcome.
The study team makes the final eligibility decision.
Where it's taking place
- Arnhem, Gelderland, Netherlands
- Nijmegen, Gelderland, Netherlands
- 's-Hertogenbosch, North Brabant, Netherlands
- Eindhoven, North Brabant, Netherlands
- Rotterdam, South Holland, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arnhem, Gelderland, Netherlands; Nijmegen, Gelderland, Netherlands; 's-Hertogenbosch, North Brabant, Netherlands; Eindhoven, North Brabant, Netherlands; Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.