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Shorter Weaning From Invasive Ventilation With Levosimendan
Sponsor: Radboud University Medical Center
Summary
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.
Official title: Shorter Weaning From Invasive Ventilation With Levosimendan: a Randomized, Double-blind, Multicentre Study in Critically Ill Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-09-17
Completion Date
2028-08-01
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
levosimendan
Participants randomized to to the intervention will receive levosimendan. The infusion is administered over 24 hours, starting at a dose of 0.1 µg/kg/min. After 4 hours, the dose may be increased to 0.2 µg/kg/min if tolerated, based on clinical judgment. A maximum of four treatment cycles may be given if the patient is not successfully weaned from mechanical ventilation within 7 days.
Soluvit
Participants randomized to this arm will receive a placebo consisting of Soluvit diluted in glucose 5%, administered as an intravenous infusion over 24 hours. The infusion will mimic the Levosimendan administration protocol, starting at 0.1 µg/kg/min and potentially increasing to 0.2 µg/kg/min after 4 hours, to maintain blinding. A maximum of four placebo treatment cycles may be administered if the patient is not successfully weaned from mechanical ventilation within 7 days.
Standard care
All patients in this arm will receive standard ICU care, including daily assessments for readiness to wean from invasive ventilation.
Locations (8)
Rijnstate Ziekenhuis Stichting
Arnhem, Gelderland, Netherlands
Intensive Care Medicine, Radboud University
Nijmegen, Gelderland, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Jeroen Bosch Ziekenhuis Stichting
's-Hertogenbosch, North Brabant, Netherlands
Catharina Ziekenhuis Stichting
Eindhoven, North Brabant, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, South Holland, Netherlands
Sint Franciscus Vlietland Groep Stichting
Rotterdam, South Holland, Netherlands
Maasstad Ziekenhuis Stichting
Rotterdam, South Holland, Netherlands