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Weaning from invasive ventilation with levosimendan (WEANLESS): study protocol for a multicentre randomised clinical
Esther De Leijer1, Charlotte Hofma1, Ary Serpa Neto2
1Department of Intensive Care, Radboudumc, Nijmegen, The Netherlands.
BMJ Open
|May 20, 2026
Summary
This study investigates levosimendan for patients struggling with mechanical ventilation weaning. Levosimendan may reduce ventilator duration and improve outcomes in difficult-to-wean intensive care unit (ICU) patients.
Area of Science:
- Critical Care Medicine
- Pharmacology
- Respiratory Medicine
Background:
- Prolonged mechanical ventilation weaning poses challenges for critically ill patients.
- Levosimendan, a calcium sensitizer, shows potential in improving respiratory muscle function.
- Its efficacy in difficult-to-wean patients remains uninvestigated.
Purpose of the Study:
- To assess if levosimendan shortens the weaning process in invasively ventilated ICU patients who fail separation attempts.
- To evaluate the effect of levosimendan on ventilator-free days and survival at day 28.
- To explore levosimendan's impact on patient-reported outcomes and healthcare resource utilization.
Main Methods:
- The WEANing with LEvoSimendan Study (WEANLESS) is a multicenter, double-blind, randomized controlled trial.
- Adult patients failing a separation attempt receive intravenous levosimendan or placebo.
- Primary outcome: ventilator-free days and alive at day 28; secondary outcomes include patient-reported data and resource utilization.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- WEANLESS is the first adequately powered study to assess intravenous levosimendan's effect on weaning duration in difficult-to-wean patients.
- Findings will determine levosimendan's clinical utility in this patient population.
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