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โ† Trials
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Shorter Weaning From Invasive Ventilation With Levosimendan

RecruitingPhase 4Ages 18 Years - anyAllRadboud University Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • levosimendan
  • Soluvit
  • Standard care
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Where

8 sites
Rijnstate Ziekenhuis Stichting
Arnhem, Netherlands
Intensive Care Medicine, Radboud University
Nijmegen, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Jeroen Bosch Ziekenhuis Stichting
's-Hertogenbosch, Netherlands
Catharina Ziekenhuis Stichting
Eindhoven, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, Netherlands
Sint Franciscus Vlietland Groep Stichting
Rotterdam, Netherlands
Maasstad Ziekenhuis Stichting
Rotterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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