Using levosimendan to shorten time on a ventilator

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

WEANLESS is a multicenter, double-blind, randomized trial enrolling 250 adults who have been invasively ventilated for more than 48 hours and failed at least one spontaneous breathing trial. Participants are randomized to a 24-hour continuous infusion of levosimendan (with a possible second dose escalation and up to four cycles if needed) or placebo, in addition to standard ICU care. The main outcome is ventilator-free days alive at day 28, and secondary follow-up includes quality-of-life measurement (EQ-5D-5L) at 3 and 12 months and daily dyspnea scores after extubation until ICU discharge. The trial is led by Radboud University Medical Center and is conducted at participating Dutch ICUs.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rijnstate Ziekenhuis Stichting
  Arnhem, Gelderland, Netherlands Recruiting
• Intensive Care Medicine, Radboud University
  Nijmegen, Gelderland, Netherlands Recruiting
• Canisius Wilhelmina Ziekenhuis
  Nijmegen, Gelderland, Netherlands Recruiting
• Jeroen Bosch Ziekenhuis Stichting
  's-Hertogenbosch, North Brabant, Netherlands Recruiting
• Sint Franciscus Vlietland Groep Stichting
  Rotterdam, South Holland, Netherlands Recruiting
• Maasstad Ziekenhuis Stichting
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Esther de Leijer, MD
• Email: esther.deleijer@radboudumc.nl
• Phone: +31243668420

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.