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Heart drug may speed ventilator weaning in ICU

NCT ID NCT07105202

Disease control Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether levosimendan, a drug that strengthens heart and breathing muscles, can help critically ill patients get off a ventilator faster. About 250 adults who have been on a breathing machine for over 48 hours and failed a breathing test will receive either the drug or a placebo. The goal is to see if the drug increases the number of days alive and free from a ventilator.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mechanical ventilation Weaning failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Canisius Wilhelmina Ziekenhuis

    RECRUITING

    Nijmegen, Gelderland, 6532SZ, Netherlands

  • Catharina Ziekenhuis Stichting

    NOT_YET_RECRUITING

    Eindhoven, North Brabant, 5623EJ, Netherlands

  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015GD, Netherlands

  • Intensive Care Medicine, Radboud University

    RECRUITING

    Nijmegen, Gelderland, 6500 HB, Netherlands

  • Jeroen Bosch Ziekenhuis Stichting

    RECRUITING

    's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

  • Maasstad Ziekenhuis Stichting

    RECRUITING

    Rotterdam, South Holland, 3079DZ, Netherlands

  • Rijnstate Ziekenhuis Stichting

    RECRUITING

    Arnhem, Gelderland, 6815AD, Netherlands

  • Sint Franciscus Vlietland Groep Stichting

    RECRUITING

    Rotterdam, South Holland, 3045 PM, Netherlands

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