Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury in Patients With ARDS - Pilot RCT
Starting soon · Phase 2/Phase 3 · Has a placebo group
Conditions studied: ARDS (Acute Respiratory Distress Syndrome), Invasive Mechanical Ventilation, Patient-Self Inflicted Lung Injury
In brief
Acute Respiratory Distress Syndrome (ARDS) is a serious condition where the lungs become inflamed, leading to severe breathing difficulties. Despite advances in medical care, ARDS remains a life-threatening illness with a high risk of death and long-term complications. One way doctors help ARDS patients is by using special ventilation techniques to protect the lungs from further damage. However, this often requires heavy sedation or even paralyzing medications, which can lead to other problems like delirium, muscle weakness, and longer hospital stays. Allowing patients to breathe on their own might offer benefits, but it also comes with risks. Many ARDS patients have a very strong urge to breathe, which can cause them to overexert their lungs, potentially leading to additional lung damage, known as patient selfinflicted lung injury (P-SILI). Our early research suggests that a medication called ondansetron, commonly used to prevent nausea, might help reduce this strong breathing drive in ARDS patients, possibly preventing further lung injury. The OSIRIS research program is designed to explore whether ondansetron can protect ARDS patients from P-SILI, ultimately improving their chances of survival and reducing long-term complications. The first part of this program, OSIRIS-1, is a small pilot study where we will test the feasibility of running a larger, more definitive trial. We will randomly assign ARDS patients to receive either ondansetron or a placebo, given intravenously four times a day, and monitor their heart rhythms closely to ensure safety. We will also track how well patients stick to the study plan and whether ondansetron helps reduce their breathing drive and lung strain. If successful, this research could lead to new ways of treating ARDS that rely less on heavy sedation, potentially improving outcomes for these critically ill patients and setting the stage for larger, more comprehensive studies in the future.
Key facts
- Study ID
- NCT07588217
- Run by
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- People needed
- 76
- Starts
- 2026-10-01
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hopital du Sacré-Coeur de Montréal — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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