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Could a common nausea drug shield ARDS lungs from further harm?

NCT ID NCT07588217

Disease control Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ondansetron, a drug typically used for nausea, can reduce the strong urge to breathe in patients with acute respiratory distress syndrome (ARDS) who are on a ventilator. By lowering this drive, the drug may prevent patients from overworking their lungs and causing additional injury. The trial will enroll 76 adults with moderate-to-severe ARDS and randomly assign them to receive ondansetron or a placebo four times daily, monitoring safety and feasibility for a larger future study.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 76 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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 to 75 years

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: * Moderate-to-severe ARDS with all of the following: * Hypoxemic respiratory failure with PaO2:FiO2 \< 200 (on IMV with PEEP ≥ 5) * Precipitated within 1 week of an acute condition * Bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on ultrasound not fully explained by effusions, atelectasis, or nodules/masses * Pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload * Hypoxemia/gas exchange abnormalities not primarily attributable to atelectasis * IMV initiated \< 96 hours * Extubation not anticipated within 24 hours Exclusion Criteria: * Neuromuscular disease impairing spontaneous breathing * Pregnancy * Liver cirrhosis (Child B or C) or other severe impairment of hepatic function * Bradycardia (baseline pulse\<50/min) on screening day * Known long QT syndrome * History of sustained ventricular tachycardia * Active digestive / abdominal infection44 * QTc prolongation \> 470 msec in men and \> 480 msec in women on screening day * On a medication at high risk of QT prolongation (Table 5)50 * On two or more serotonergic medications (Table 6)51 * Hypersensitivity / intolerance to 5-HT3 antagonists * Patient deemed unlikely to survive past 24 hours or being transitioned to a fully palliative philosophy of care

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome

As listed by the trial registrant

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

ARDS (acute respiratory distress syndrome) Invasive mechanical ventilation Patient-self inflicted lung injury

How to take part

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

  1. The places running it

    1 site. 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

  • Hopital du Sacré-Coeur de Montréal

    Montreal, Quebec, H4J 1C5, Canada

More trials for these conditions

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