Effects of Ondansetron on Breathing in Patients with ARDS
Effect of a 5-HT3 Receptor Antagonist on Respiratory Drive in Spontaneously Breathing Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS): a Pilot Proof-of-concept Crossover Non-randomized Controlled Trial
This study is testing if ondansetron can help improve breathing and reduce lung injury in patients with acute respiratory distress syndrome (ARDS) who are on mechanical ventilation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hopital du Sacre-Coeur de Montreal Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT05514483 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the impact of a 5-HT3 receptor antagonist, ondansetron, on respiratory drive in patients suffering from acute respiratory distress syndrome (ARDS). It aims to gather primary physiological data to assess the feasibility of using ondansetron to reduce patient self-inflicted lung injury (P-SILI) in ARDS. Participants will be monitored while receiving either ondansetron or a placebo during mechanical ventilation. The findings will inform future studies on the clinical applications of this treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who meet the Berlin Criteria for ARDS and require mechanical ventilation.
Not a fit: Patients who have received a 5-HT3 antagonist within the last 24 hours or have contraindications for its use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of respiratory drive in ARDS patients, potentially reducing lung injury.
How similar studies have performed: While this approach is novel in the context of ARDS, similar studies with ondansetron have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (18-75 years old) * Berlin Criteria for Acute Respiratory Distress Syndrome (ARDS) (1): * Hypoxemic respiratory failure with a patrial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2:FiO2 ratio) \< 300 * Bilateral opacities not fully explained by effusions, lung/lobar collapse, or nodules on chest imaging that appeared within 7 days of a known clinical insult * Respiratory failure not fully explained by cardiac failure or fluid overload * Has been mechanically ventilated \> 48 hours * Planned to remain mechanically ventilated for the next 24 hours * Currently on Pressure Support Ventilation or planning to go on pressure support ventilation in the next 24 hours Exclusion Criteria: * Having received a 5-HT3 antagonist in the last 24 hours, or planning to use one in the next 24 hours * Recently treated for bleeding varices, stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement * Severe coagulopathy (platelet count\< 10 000 or International Normalized Ratio (INR) \> 3) * Neuromuscular disease that impairs ability to ventilate spontaneously (including C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barre syndrome or myasthenia gravis) * Treating clinician refusal, or unwillingness to commit to pressure support ventilation for at least 6 hours. * Pregnancy * Liver cirrhosis (Child B or C) or other severe impairment of hepatic function * Congestive heart failure * Bradyarrhythmia (baseline pulse\<55/min) * Known long QT syndrome * QTc prolongation\>450 msec, noted on prior or screening ECG, or who are taking medication known to cause QT prolongation * Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists
Where this trial is running
Montréal, Quebec
- Hôpital Sacré-Coeur de Montréal — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Yiorgos Alexandros Cavayas, MD MSc FRCPC — Hopital du Sacré Coeur de Montréal, Centre de recherche du centre intégré universitaire de santé et services sociaux du Nord-de-l'Ile-de-Montréal
- Study coordinator: Virginie Williams
- Email: virginie.williams.cnmtl@ssss.gouv.qc.ca
- Phone: 514-338-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.