Ondansetron for Acute Respiratory Distress Syndrome
(OSIRIS-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether ondansetron, a drug commonly used to prevent nausea, can help patients with Acute Respiratory Distress Syndrome (ARDS) breathe more easily without causing additional lung damage. ARDS is a serious condition characterized by lung inflammation and severe breathing difficulties. The study compares ondansetron to a placebo to determine if it reduces the intense urge to breathe, which can further harm the lungs. This trial includes individuals experiencing severe breathing issues due to ARDS, who have recently started mechanical ventilation, and are not expected to be taken off the ventilator soon. The goal is to find safer ways to manage breathing in ARDS patients without heavily relying on strong sedatives. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot participate if you are on a medication at high risk of QT prolongation or on two or more serotonergic medications. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that ondansetron is likely to be safe for humans?
Research has shown that ondansetron, a medication commonly used to prevent nausea, is safe according to various studies. Specifically, studies have demonstrated that early use of ondansetron in patients with serious breathing problems is linked to a lower risk of death within 30 days, suggesting its potential benefit in critical situations.
Reports of side effects with ondansetron exist, and databases like FAERS monitor these. It's important to understand that side effects are common with medications, and the benefits might outweigh the risks, especially in severe conditions like ARDS.
The FDA has approved ondansetron for other treatments, indicating confidence in its safety when used correctly. This trial will closely monitor patients for any changes in heart rhythm to ensure ondansetron's safety in treating ARDS.12345Why do researchers think this study treatment might be promising for ARDS?
Ondansetron is unique because, unlike typical treatments for Acute Respiratory Distress Syndrome (ARDS) like corticosteroids and supportive care, it targets serotonin receptors, offering a novel approach to managing the inflammatory response in the lungs. Most ARDS treatments focus on reducing inflammation or supporting breathing, but ondansetron’s mechanism, commonly used to treat nausea, could help modulate the body's reaction to lung injury differently. Researchers are excited about this treatment because it might offer quicker relief by addressing the underlying inflammation through a new pathway, potentially leading to better outcomes for patients on mechanical ventilation.
What evidence suggests that ondansetron might be an effective treatment for ARDS?
Research has shown that ondansetron might help lower the risk of death in people with acute respiratory distress syndrome (ARDS). In this trial, participants will receive either ondansetron or a placebo. One study found that patients who received ondansetron early were less likely to die within 30 days compared to those who did not receive it. Ondansetron blocks certain signals in the brain, which can help reduce the urge to breathe too hard. This might protect the lungs from further damage in ARDS patients. Early findings suggest that ondansetron could be a promising option for improving outcomes in people with ARDS.13467
Who Is on the Research Team?
David Williamson, BPharm, PhD
Principal Investigator
Centre Intégré Universitaire de Santé et Services Sociaux du Nord-de-l'Ile-de-Montréal - Hôpital du Sacré-Coeur de Montréal
Yiorgos Alexandros Cavayas, MD MSc
Principal Investigator
Centre Intégré Universitaire de Santé et Services Sociaux du Nord-de-l'Ile-de-Montréal - Hôpital du Sacré-Coeur de Montréal
Are You a Good Fit for This Trial?
This trial is for adults with ARDS (acute respiratory distress syndrome) who are on mechanical ventilation. Participants must be able to receive intravenous medications and will be closely monitored in the hospital.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ondansetron or placebo intravenously every 8 hours until liberation from invasive mechanical ventilation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ondansetron
Trial Overview
The study tests whether ondansetron, a drug usually used for nausea, can help protect the lungs of ARDS patients from further injury by reducing their urge to breathe too hard. Patients are randomly given either ondansetron or a placebo through an IV every 8 hours.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The first dose of intravenous ondansetron will be administered within 24 hours of randomization, every 8 hours, for duration of invasive mechanical ventilation.
The first dose of intravenous placebo will be administered within 24 hours of randomization, every 8 hours, for duration of invasive mechanical ventilation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead Sponsor
Citations
Association of early ondansetron use with 30-day mortality in ...
Early OND use and daily low-dose OND use before MV support were associated with a decreased risk of 30-day mortality, which may be beneficial for the rational ...
Ondansetron for the Prevention of Patient Self-Inflicted ...
Our previous data suggest that 3 ondansetron, a 5-HT receptor antagonist, attenuates respiratory drive and effort. We hypothesize that 3 this ...
Association of early ondansetron use with 30-day mortality ...
After PSM, patients who received early OND use had lower odds of 30-day mortality compared with those who did not (HR =0.77, 95% CI: 0.63-0.94).
Association of early ondansetron use with 30-day mortality in ...
Association of early ondansetron use with 30-day mortality in patients with acute respiratory distress syndrome: a retrospective cohort study.
5-HT3 Receptor Antagonist and Respiratory Drive in ...
This is a pilot study aimed at acquiring primary physiological data, describing and estimating the effects of a 5-HT3 receptor antagonist (ondansetron) on ...
Ondansetron for the Prevention of Patient Self-Inflicted ...
Our previous data suggest that 3 ondansetron, a 5-HT receptor antagonist, attenuates respiratory drive and effort. We hypothesize that 3 this ...
A real-world safety signal detection study of ondansetron ...
From Q1 2014 to Q1 2024, 9,413 adverse event (AE) reports were linked to Ondansetron as the primary suspect drug in the FAERS database, with a ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.