Mechanical VentilationPhase 4WEANLESSNCT07105202
Shorter Weaning From Invasive Ventilation With Levosimendan
A Phase 4 study testing levosimendan and Soluvit in people with Mechanical Ventilation and Weaning Failure, run by Radboud University Medical Center at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Weaning Failure
- What is being tested?
- levosimendan and Soluvit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 8 sitesNetherlands
- Study dates
- 17 Sep 2025to 1 Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasively ventilated > 48 hours.
- Failed at least one spontaneous breathing trial (SBT).
- Age above 18 years.
- Female patients with age < 60 must have a negative pregnancy test (blood or urine) prior to participation.
Who cannot join
- Pre-existing neuromuscular disease (congenital or acquired)
- Endotracheally intubated primarily for neurological reason (e.g., traumatic brain injury, intracranial haemorrhage, epilepsy, intracranial infection), or developed severe intracranial haemorrhage/infarction during ICU stay.
- Contra-indications for levosimendan: severe renal failure (creatinine clearance <30mL/min) unless managed with appropriate continuous kidney replacement therapy (such as CRRT), severe liver failure (Child-Pugh class C), history of torsade des pointes; known significant mechanical obstructions affecting ventricular filling/ outflow or both; prolonged QTc interval (QTc > 470ms); breast feeding; known hypersensitivity to levosimendan.
- Treatment with intermittent haemodialysis.
- Treatment limitation decision in place: do not reintubate
- Previous treatment with levosimendan within 30 days.
- Currently in another interventional trial that might interact with study drug or primary outcome.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Leo Heunks, MD, PhD contact
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis Stichting
's-Hertogenbosch, North Brabant, 5223GZ
Koen Simons, Dr., +31735532447, k.simons@jbz.nl
- Recruiting
Rijnstate Ziekenhuis Stichting
Arnhem, Gelderland, 6815AD
Aart Strang, Mr., +31880056969, astrang@rijnstate.nl
- Not yet recruiting
Catharina Ziekenhuis Stichting
Eindhoven, North Brabant, 5623EJ
Ashley de Bie, Dr., +31402399500, ashley.d.bie@catharinaziekenhuis.nl
- Recruiting
Intensive Care Medicine, Radboud University
Nijmegen, Gelderland, 6500 HB
Esther de Leijer, MD, +31243668420, esther.deleijer@radboudumc.nl
Leo Heunks, MD, PhD
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532SZ
Oscar Hoiting, Dr., +31243657560, o.hoiting@cwz.nl
- Not yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, South Holland, 3015GD
Annemijn Jonkman, Dr., +31107035142, a.jonkman@erasmusmc.nl
- Recruiting
Sint Franciscus Vlietland Groep Stichting
Rotterdam, South Holland, 3045 PM
Evert-Jan Wils, +31104616161, e.wils@franciscus.nl
- Recruiting
Maasstad Ziekenhuis Stichting
Rotterdam, South Holland, 3079DZ
Corstiaan den Uil, Mr., +31102913088, uilc@maasstadziekenhuis.nl
About this study
Official title: Shorter Weaning From Invasive Ventilation With Levosimendan: a Randomized, Double-blind, Multicentre Study in Critically Ill Patients
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.
Read the detailed description
Objective: To assess the effect of levosimendan on the number of ventilator-free days up until day 28.
Study design: WEANLESS is an investigator-initiated, multicenter, double blind, randomized clinical superiority trial in ventilated adult patients admitted to the ICUs of participating hospitals.
Study population: This study will include 250 patients who are invasively ventilated for more than 48 hours and failed at least one SBT. Patients are enrolled from participating ICUs and randomized within 24 hours after failing their first SBT.
Intervention:
Patients will be randomly assigned in a double-blind manner to receive either levosimendan or placebo. The study medication will be administered as a continuous intravenous infusion over 24 hours, starting at a dose of 0.1 µg/kg/min, with the option to increase to 0.2 µg/kg/min after 4 hours if well tolerated. If weaning is not successful after 7 days, a maximum of four treatment cycles may be given. All patients will continue to receive standard ICU care, including daily assessments of readiness to wean from mechanical ventilation.
In addition to the intervention, health-related quality of life will be assessed using the EQ-5D-5L questionnaire at baseline, 3 months, and 12 months after inclusion. Dyspnea scores will be recorded daily after extubation until ICU discharge.
Main study parameters/endpoints: The primary endpoint of the study is the number of ventilator-free days and alive (VFD) at day 28 from randomization. This is a composite endpoint combining both mortality and the duration of ventilation. Secondary outcomes include ventilator-free days at day 90, dyspnea scores, reintubation rates, ICU readmission, ICU length of stay, hospital length of stay and mortality. Safety outcomes include the occurrence of cardiac arrhythmias, changes in vasopressor requirements and other adverse events related to levosimendan.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for participants is minimal. Levosimendan is a registered drug with a known safety profile and is already used in critical care settings. The placebo is an infusion with Soluvit. All other care follows standard ICU procedures. Data will be collected from the electronic medical record and routine monitoring. No additional invasive procedures are required solely for the main study.
- Conditions
- Mechanical Ventilation, Weaning Failure
- Being tested
- levosimendan, Soluvit, Standard care
- Keywords
- mechanical ventilation, weaning, critically ill patients, levosimendan, diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
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.
SoluvitDrug
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 careOther
All patients in this arm will receive standard ICU care, including daily assessments for readiness to wean from invasive ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Participants randomized to this arm will receive intravenous levosimendan. This group will consist of 125 patients. Receives: Drug: levosimendan; Other: Standard care |
| Control group | Placebo comparator | Participants randomized to this arm will receive a placebo consisting of Soluvit. This group will consist of 125 participants. Receives: Drug: Soluvit; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is the number of ventilator-free days and alive (VFD) at day 28 from randomization. This is a composite endpoint combining both mortality and the duration of ventilation.
In case of death, the subject will be assigned a value of 0 VFD. Day 0 will be defined as the day of randomization.
Measured: From randomization up until day 28.
Secondary outcomes (17)
The number of ventilator-free days from randomization up until day 90.
Measured: From randomization up until day 90.
The number of days from randomization to successful weaning from invasive ventilation.
Weaning success defined as: for intubated patients extubation without death or reintubation within the next 7 days, or discharge from the ICU without invasive ventilation within 7 days. Whichever comes first.
For tracheostomized patients, weaning success is defined as ventilation through tracheostomy without any invasive ventilation during 7 consecutive days, or discharged from the ICU with unassisted breathing, whichever came first.
Measured: From randomization up until day 90.
ICU mortality
Measured: From randomization up until day 28.
ICU mortality
Measured: From randomization up until day 90.
Dyspnea sensation
Dyspnea will be assessed daily at the end of the spontaneous breathing trial using the Visual Analogue Scale (VAS). This is a scale from 0 to 10, where 0 means no dyspnea sensation at all and 10 the worst you have ever experiences. After extubation, dyspnea scores will be recorded daily in the morning until ICU discharge. Dyspnea sensation will be quantified as the median score from the first to the last measurement and a difference of ≥1 point on the VAS will be considered clinically meaningful.
Measured: From extubation up until day 28 or ICU discharge whichever comes first.
Quality of life at baseline and at follow up after 3 and 12 months.
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire will be used to assess health-related quality of life at baseline, and again at 3 and 12 months after randomization. Higher scores indicates better health status.
Measured: From randomization up until 3 and 12 months.
The number of patients with a reintubation (for endotracheally intubated patients) or reinstitution of invasive ventilation (for tracheostomized patients) within 7 days after liberation.
An endotracheal intubation beyond 7 days is not considered a "reintubation" but will be classified as a new event.
Measured: From randomization up until day 90.
ICU readmission within 90 days.
Measured: From randomization up until day 90.
The number of days with non-invasive respiratory support (high flow nasal canula or non-invasive ventilation).
Measured: From randomization up until day 28.
The length of stay in the ICU.
Measured: From randomization up until day 90.
The length of stay in the hospital.
Measured: From randomization up until day 90.
Plasma concentration of levosimendan
Blood samples will be collected at predefined time points ( after 24 hours, 48 hours, 72 hours and 120 hours) to determine the plasma concentration of levosimendan following intravenous administration.
Measured: From 24 hours after start of the first dose of medication up until 120 hours after start of the fist dose of medication.
Incidence of clinically significant blood pressure change
Number of participants with a deviation of ≥20% from baseline mean arterial pressure (MAP), sustained for at least 10 minutes, as monitored continuously during infusion as part of routine ICU care.
Measured: From randomization until day 28 or ICU discharge whichever comes first.
Incidence of clinically significant heart rate change
Number of participants with a deviation of ≥20% from baseline heart rate, sustained for at least 10 minutes, as monitored continuously during infusion as part of routine ICU care.
Measured: From randomization until day 28 or ICU discharge whichever comes first.
Vasopressor and inotropic durg use during ICU stay
Use of vasopressors and/or inotropic drugs will be recorded daily from the start of study medication until ICU discharge. Data collected will include the generic drug name and daily dose.
Measured: From randomization until ICU discharge or day 28 whichever comes first.
Incidence and type of cardiac dysrhythmia detected by continuous ECG monitoring
Continuous ECG monitoring will be used to detect cardiac dysrhythmias up to 30 hours after initiation of study medication. Detected dysrhythmias will be categorized by type.
Measured: From start of infusion up to 30 hours after initiation
Daily fluid balance
Daily assessment of the fluidbalance
Measured: From randomization up until day 28 or discharge on the ICU, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start17 Sep 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105202
- Sponsor's protocol ID
- 2024-518810-23-00
- Other IDs
- 2024-518810-23-00
- Acronym
- WEANLESS
- Status last verified
- May 2025
- First submitted
- 9 Jul 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Leijer E, Hofma C, Serpa Neto A, Hunfeld NGM, Schultz MJ, Doorduin J, Heunks L. Weaning from invasive ventilation with levosimendan (WEANLESS): study protocol for a multicentre randomised clinical trial. BMJ Open. 2026 May 20;16(5):e117615. doi: 10.1136/bmjopen-2026-117615.
PubMed 42161542
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shorter Weaning From Invasive Ventilation With Levosimendan: a Randomized, Double-blind, Multicentre Study in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07105202
- Acronym / sponsor ID
- WEANLESS / 2024-518810-23-00
- Conditions
- Mechanical Ventilation, Weaning Failure
- Keywords
- mechanical ventilation, weaning, critically ill patients, levosimendan, diaphragm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: To assess the effect of levosimendan on the number of ventilator-free days up until day 28.
Study design: WEANLESS is an investigator-initiated, multicenter, double blind, randomized clinical superiority trial in ventilated adult patients admitted to the ICUs of participating hospitals.
Study population: This study will include 250 patients who are invasively ventilated for more than 48 hours and failed at least one SBT. Patients are enrolled from participating ICUs and randomized within 24 hours after failing their first SBT.
Intervention:
Patients will be randomly assigned in a double-blind manner to receive either levosimendan or placebo. The study medication will be administered as a continuous intravenous infusion over 24 hours, starting at a dose of 0.1 µg/kg/min, with the option to increase to 0.2 µg/kg/min after 4 hours if well tolerated. If weaning is not successful after 7 days, a maximum of four treatment cycles may be given. All patients will continue to receive standard ICU care, including daily assessments of readiness to wean from mechanical ventilation.
In addition to the intervention, health-related quality of life will be assessed using the EQ-5D-5L questionnaire at baseline, 3 months, and 12 months after inclusion. Dyspnea scores will be recorded daily after extubation until ICU discharge.
Main study parameters/endpoints: The primary endpoint of the study is the number of ventilator-free days and alive (VFD) at day 28 from randomization. This is a composite endpoint combining both mortality and the duration of ventilation. Secondary outcomes include ventilator-free days at day 90, dyspnea scores, reintubation rates, ICU readmission, ICU length of stay, hospital length of stay and mortality. Safety outcomes include the occurrence of cardiac arrhythmias, changes in vasopressor requirements and other adverse events related to levosimendan.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for participants is minimal. Levosimendan is a registered drug with a known safety profile and is already used in critical care settings. The placebo is an infusion with Soluvit. All other care follows standard ICU procedures. Data will be collected from the electronic medical record and routine monitoring. No additional invasive procedures are required solely for the main study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: levosimendan, Other: Standard careParticipants randomized to this arm will receive intravenous levosimendan. This group will consist of 125 patients. |
| Control group | Placebo comparator | Drug: Soluvit, Other: Standard careParticipants randomized to this arm will receive a placebo consisting of Soluvit. This group will consist of 125 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Invasively ventilated > 48 hours.
- Failed at least one spontaneous breathing trial (SBT).
- Age above 18 years.
- Female patients with age < 60 must have a negative pregnancy test (blood or urine) prior to participation.
Key exclusion criteria (7 listed)
- Pre-existing neuromuscular disease (congenital or acquired)
- Endotracheally intubated primarily for neurological reason (e.g., traumatic brain injury, intracranial haemorrhage, epilepsy, intracranial infection), or developed severe intracranial haemorrhage/infarction during ICU stay.
- Contra-indications for levosimendan: severe renal failure (creatinine clearance <30mL/min) unless managed with appropriate continuous kidney replacement therapy (such as CRRT), severe liver failure (Child-Pugh class C), history of torsade des pointes; known significant mechanical obstructions affecting ventricular filling/ outflow or both; prolonged QTc interval (QTc > 470ms); breast feeding; known hypersensitivity to levosimendan.
- Treatment with intermittent haemodialysis.
- Treatment limitation decision in place: do not reintubate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levosimendanParticipants 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 | Intervention group |
| SoluvitParticipants 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. | Drug | Control group |
| Standard careAll patients in this arm will receive standard ICU care, including daily assessments for readiness to wean from invasive ventilation. | Other | Control group, Intervention group |
Primary outcome
The primary endpoint of the study is the number of ventilator-free days and alive (VFD) at day 28 from randomization. This is a composite endpoint combining both mortality and the duration of ventilation.
Time frame: From randomization up until day 28.
In case of death, the subject will be assigned a value of 0 VFD. Day 0 will be defined as the day of randomization.
17 secondary outcomes
The number of ventilator-free days from randomization up until day 90.
Time frame: From randomization up until day 90.
The number of days from randomization to successful weaning from invasive ventilation.
Time frame: From randomization up until day 90.
ICU mortality
Time frame: From randomization up until day 28.
ICU mortality
Time frame: From randomization up until day 90.
Dyspnea sensation
Time frame: From extubation up until day 28 or ICU discharge whichever comes first.
Quality of life at baseline and at follow up after 3 and 12 months.
Time frame: From randomization up until 3 and 12 months.
The number of patients with a reintubation (for endotracheally intubated patients) or reinstitution of invasive ventilation (for tracheostomized patients) within 7 days after liberation.
Time frame: From randomization up until day 90.
ICU readmission within 90 days.
Time frame: From randomization up until day 90.
The number of days with non-invasive respiratory support (high flow nasal canula or non-invasive ventilation).
Time frame: From randomization up until day 28.
The length of stay in the ICU.
Time frame: From randomization up until day 90.
The length of stay in the hospital.
Time frame: From randomization up until day 90.
Plasma concentration of levosimendan
Time frame: From 24 hours after start of the first dose of medication up until 120 hours after start of the fist dose of medication.
Incidence of clinically significant blood pressure change
Time frame: From randomization until day 28 or ICU discharge whichever comes first.
Incidence of clinically significant heart rate change
Time frame: From randomization until day 28 or ICU discharge whichever comes first.
Vasopressor and inotropic durg use during ICU stay
Time frame: From randomization until ICU discharge or day 28 whichever comes first.
Incidence and type of cardiac dysrhythmia detected by continuous ECG monitoring
Time frame: From start of infusion up to 30 hours after initiation
Daily fluid balance
Time frame: From randomization up until day 28 or discharge on the ICU, whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Derived from this study: PubMed 42161542De Leijer E, Hofma C, Serpa Neto A, Hunfeld NGM, Schultz MJ, Doorduin J, Heunks L. Weaning from invasive ventilation with levosimendan (WEANLESS): study protocol for a multicentre randomised clinical trial. BMJ Open. 2026 May 20;16(5):e117615. doi: 10.1136/bmjopen-2026-117615.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leo Heunks, MD, PhD contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levosimendan and Soluvit in people with Mechanical Ventilation and Weaning Failure, run by Radboud University Medical Center at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther de Leijer, MD (+31243668420, esther.deleijer@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the number of ventilator-free days and alive (VFD) at day 28 from randomization. This is a composite endpoint combining both mortality and the duration of ventilation. (time frame: From randomization up until day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07105202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.