Actively Recruiting
Shorter Weaning From Invasive Ventilation With Levosimendan
Led by Radboud University Medical Center · Updated on 2026-01-09
250
Participants Needed
8
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Shorter Weaning From Invasive Ventilation With Levosimendan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Invasively ventilated for more than 48 hours
- Failed at least one spontaneous breathing trial
- Age above 18 years
- Female patients under 60 years must have a negative pregnancy test (blood or urine) prior to participation
You will not qualify if you...
- Pre-existing neuromuscular disease (congenital or acquired)
- Intubated primarily for neurological reasons or developed severe intracranial haemorrhage/infarction during ICU stay
- Contraindications for levosimendan including severe renal failure, severe liver failure, history of torsade des pointes, significant heart obstructions, prolonged QTc interval, breastfeeding, or hypersensitivity to levosimendan
- Treatment with intermittent haemodialysis
- Treatment limitation decision in place: do not reintubate
- Previous levosimendan treatment within 30 days
- Currently enrolled in another interventional trial that could affect study drug or outcomes
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Rijnstate Ziekenhuis Stichting
Arnhem, Gelderland, Netherlands, 6815AD
Actively Recruiting
2
Intensive Care Medicine, Radboud University
Nijmegen, Gelderland, Netherlands, 6500 HB
Actively Recruiting
3
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532SZ
Actively Recruiting
4
Jeroen Bosch Ziekenhuis Stichting
's-Hertogenbosch, North Brabant, Netherlands, 5223GZ
Actively Recruiting
5
Catharina Ziekenhuis Stichting
Eindhoven, North Brabant, Netherlands, 5623EJ
Not Yet Recruiting
6
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, South Holland, Netherlands, 3015GD
Not Yet Recruiting
7
Sint Franciscus Vlietland Groep Stichting
Rotterdam, South Holland, Netherlands, 3045 PM
Actively Recruiting
8
Maasstad Ziekenhuis Stichting
Rotterdam, South Holland, Netherlands, 3079DZ
Actively Recruiting
Research Team
E
Esther de Leijer, MD
CONTACT
L
Leo Heunks, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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