Shorter Weaning From Invasive Ventilation With Levosimendan

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

August 1, 2027

Study Completion Date

August 1, 2028

Conditions
Mechanical VentilationWeaning Failure
Interventions
DRUG

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.

DRUG

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.

OTHER

Standard care

All patients in this arm will receive standard ICU care, including daily assessments for readiness to wean from invasive ventilation.

Trial Locations (8)

6815AD

Rijnstate Ziekenhuis Stichting, Arnhem

6500 HB

Intensive Care Medicine, Radboud University, Nijmegen

6532SZ

Canisius Wilhelmina Ziekenhuis, Nijmegen

5223GZ

Jeroen Bosch Ziekenhuis Stichting, 's-Hertogenbosch

5623EJ

Catharina Ziekenhuis Stichting, Eindhoven

3015GD

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Rotterdam

3045 PM

Sint Franciscus Vlietland Groep Stichting, Rotterdam

3079DZ

Maasstad Ziekenhuis Stichting, Rotterdam

All Listed Sponsors
lead

Radboud University Medical Center

OTHER