250
Participants
Start Date
August 15, 2025
Primary Completion Date
August 1, 2027
Study Completion Date
August 1, 2028
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.
Rijnstate Ziekenhuis Stichting, Arnhem
Intensive Care Medicine, Radboud University, Nijmegen
Canisius Wilhelmina Ziekenhuis, Nijmegen
Jeroen Bosch Ziekenhuis Stichting, 's-Hertogenbosch
Catharina Ziekenhuis Stichting, Eindhoven
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Rotterdam
Sint Franciscus Vlietland Groep Stichting, Rotterdam
Maasstad Ziekenhuis Stichting, Rotterdam
Radboud University Medical Center
OTHER