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5-HT3 Receptor Antagonist

Ondansetron for Acute Respiratory Distress Syndrome (DRIVE Trial)

Phase 4
Recruiting
Led By Yiorgos Alexandros Cavayas, MD MSc FRCPC
Research Sponsored by Hopital du Sacre-Coeur de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently on Pressure Support Ventilation or planning to go on pressure support ventilation in the next 24 hours
Respiratory failure not fully explained by cardiac failure or fluid overload
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly through study completion (estimated 6 months)
Awards & highlights

DRIVE Trial Summary

This trial will study the effects of a drug called ondansetron on respiratory drive in patients with acute respiratory distress syndrome (ARDS), with the aim of reducing patient self-inflicted lung injury (P-SILI) in ARDS.

Who is the study for?
This trial is for adults aged 18-75 with ARDS who are on or will be on pressure support ventilation. They must have specific respiratory failure criteria, been ventilated >48 hours, and expected to continue for the next 24 hours. Excluded are those with certain heart rates, drug sensitivities, congestive heart failure, recent gastrointestinal treatments, severe coagulopathy, pregnancy, long QT syndrome or neuromuscular diseases.Check my eligibility
What is being tested?
The study tests if Ondansetron (a drug blocking certain receptors) affects breathing drive in ARDS patients compared to a placebo. It's a pilot study gathering initial data to see if this treatment can reduce lung injury caused by the patient's own breathing efforts.See study design
What are the potential side effects?
Ondansetron may cause headaches, constipation or diarrhea; it could also lead to serious side effects like changes in heartbeat rhythm. The exact side effects in ARDS patients will be further explored in this study.

DRIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently using or will use a breathing support machine within 24 hours.
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My breathing issues are not due to heart failure or fluid in my body.
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My oxygen levels are very low compared to the amount of oxygen I'm breathing in.
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I am between 18 and 75 years old.

DRIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly through study completion (estimated 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly through study completion (estimated 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pressure-time product of the esophageal pressure per minute
Secondary outcome measures
Area under the Eadi curve
Corrected QT length (QTc)
Critical care Pain Observation Tool (CPOT)
+16 more
Other outcome measures
Enrolment

DRIVE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: OndansetronActive Control1 Intervention
All participants will receive a single injection of placebo, followed, three hours later, by a single injection of ondansetron.
Group II: PlaceboPlacebo Group1 Intervention
All participants will receive a single injection of placebo, followed, three hours later, by a single injection of ondansetron.

Find a Location

Who is running the clinical trial?

Fonds de la Recherche en Santé du QuébecOTHER_GOV
80 Previous Clinical Trials
46,538 Total Patients Enrolled
Hopital du Sacre-Coeur de MontrealLead Sponsor
51 Previous Clinical Trials
12,259 Total Patients Enrolled
Yiorgos Alexandros Cavayas, MD MSc FRCPCPrincipal InvestigatorHopital du Sacré Coeur de Montréal, Centre de recherche du centre intégré universitaire de santé et services sociaux du Nord-de-l'Ile-de-Montréal

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects might be experienced from Ondansetron Injection?

"Ondansetron Injection has been evaluated to a score of 3 as it is currently approved, which falls under the parameters of Phase 4 trials."

Answered by AI

Is the scope of this experiment restricted to those aged thirty or younger?

"This trial is accessible to individuals between 18 to 75 years of age. As an alternative, those below or above this range can look into 410 trials for minors and 1091 clinical research studies open to seniors."

Answered by AI

Are there opportunities for me to participate in this experiment?

"This clinical trial seeks to enrol 10 participants suffering from Respiratory Distress Syndrome, aged between 18 and 75. Notably, applicants must fulfil the following criteria: remain on mechanical ventilation for 24 hours; be currently connected or plan to be connected to Pressure Support Ventilation within a day; have an oxygen-to-fraction ratio of PaO2/FiO2 lower than 300; display chest imaging with bilateral opacity that cannot fully be explained by effusions, lung collapse or nodules appearing in seven days since their last known illness episode; and need to have been mechanically ventilated for more than 48 hours."

Answered by AI

Are any openings available for potential participants in this clinical trial?

"The data located on clinicaltrials.gov suggests that this experiment is not actively recruiting participants at the moment, as it was first posted in November 25th 2022 and last updated 24 hours prior to writing this answer. Nonetheless, there are a plethora of other medical trials open for enrollment presently-- 1,527 total."

Answered by AI
~4 spots leftby Mar 2025