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Acute Respiratory Distress SyndromePhase 4DRIVENCT05514483

5-HT3 Receptor Antagonist and Respiratory Drive in Patients With ARDS

A Phase 4 study testing Ondansetron in people with Acute Respiratory Distress Syndrome, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a pilot study aimed at acquiring primary physiological data, describing and estimating the effects of a 5-HT3 receptor antagonist (ondansetron) on respiratory drive in patients with acute respiratory distress syndrome (ARDS). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
Ondansetron
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteCanada
Study dates
10 Nov 2022to 6 May 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Virginie Williams contact

514-338-2222 ext. 583327

virginie.williams.cnmtl@ssss.gouv.qc.ca

Canada1 site, 1 recruiting

  • Hôpital Sacré-Coeur de Montréal

    Montreal, Quebec, H4J1C5

    Virginie Williams, PhD, 514-338-2222 ext. 583327, virginie.williams.cnmtl@ssss.gouv.qc.ca

    Yiorgos Alexandros Cavayas, MD MSc FRCPC

    Recruiting

Other trials in Canada

About this study

Official title: 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 is a pilot study aimed at acquiring primary physiological data, describing and estimating the effects of a 5-HT3 receptor antagonist (ondansetron) on respiratory drive in patients with acute respiratory distress syndrome (ARDS). The results of this study will determine the interest and feasibility of assessing the clinical applications of ondansetron in reducing patient self-inflicted lung injury (P-SILI) in ARDS, in subsequent studies.

Being tested
Placebo, Ondansetron
Keywords
ARDS, Ondansetron
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called NaCl 0.9%, Normal Saline, Sodium chloride

    Single intravenous dose of 10 mL of sodium chloride (NaCl) 0.9% over 15 minutes.

  • OndansetronDrug

    Also called Ondansetron hydrochloride dihydrate

    Single intravenous dose of ondansetron hydrochloride dihydrate 0.15 mg/kg (maximum 16 mg) in 10 mL of NaCl 0.9% over 15 minutes.

Study groups in NCT05514483
Study groupRoleWhat they receive
PlaceboPlacebo comparatorAll participants will receive a single injection of placebo, followed, three hours later, by a single injection of ondansetron.
Receives: Drug: Placebo
OndansetronActive comparatorAll participants will receive a single injection of placebo, followed, three hours later, by a single injection of ondansetron.
Receives: Drug: Ondansetron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure-time product of the esophageal pressure per minute

    Difference in mean pressure-time product of the esophageal pressure per minute between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

Secondary outcomes (19)

  1. Respiratory rate

    Difference in mean respiratory rate between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  2. Tidal volume

    Difference in mean tidal volume between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  3. Pressure-time product of the esophageal pressure per breath

    Difference in mean pressure-time product of the esophageal pressure per breath between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  4. Esophageal pressure swings

    Difference in mean esophageal pressure swings between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  5. Transpulmonary pressure swings

    Difference in mean transpulmonary pressure swings between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  6. Estimated occlusion pressure at 0.1 msec (P0.1)

    Difference in mean estimated occlusion pressure at 0.1 msec (P0.1) between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  7. Peak electrical activity of the diaphragm (Eadi)

    Difference in mean peak Eadi between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  8. Area under the Eadi curve

    Difference in area under the Eadi curve between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  9. End-tidal CO2 (EtCO2)

    Difference in mean EtCO2 between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  10. Volume of expired CO2 (VCO2)

    Difference in mean VCO2 between placebo phase and ondansetron phase

    Measured: Continuous measurement during each 2-hour phase

  11. Oxygen saturation estimated by pulse oximetry (SpO2)

    Difference in mean SpO2 between placebo phase and ondansetron phase

    Measured: Measurement every 5 minutes during each 2-hour phase

  12. Partial pressure of carbon dioxide in arterial blood (PaCO2)

    Difference in mean PaCO2 between placebo phase and ondansetron phase

    Measured: Measurement every 30 minutes during each 2-hour phase

  13. Partial pressure of oxygen in arterial blood (PaO2)

    Difference in mean PaO2 between placebo phase and ondansetron phase

    Measured: Measurement every 30 minutes during each 2-hour phase

  14. Heart rate

    Difference in mean heart rate between placebo phase and ondansetron phase

    Measured: Measurement every 5 minutes during each 2-hour phase

  15. Mean arterial pressure (MAP)

    Difference in mean MAP between placebo phase and ondansetron phase

    Measured: Measurement every 5 minutes during each 2-hour phase

  16. Corrected QT length (QTc)

    Difference in QTc between placebo phase and ondansetron phase

    Measured: Measurement once (at the 1 hour-mark) during each 2-hour phase

  17. Temperature

    Difference in mean temperature between placebo phase and ondansetron phase

    Measured: Hourly measurement during each 2-hour phase

  18. Richmond Agitation and Sedation Scale (RASS)

    Difference in mean Richmond Agitation and Sedation Scale (RASS) between placebo phase and ondansetron phase. This scale goes from -5 (unraousable) to +4 (combative).

    Measured: Hourly measurement during each 2-hour phase

  19. Critical care Pain Observation Tool (CPOT)

    Difference in mean Critical care Pain Observation Tool (CPOT) between placebo phase and ondansetron phase. This scale goes from 0 (lowest pain level) to 10 (highest pain level).

    Measured: Hourly measurement during each 2-hour phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start10 Nov 2022
  3. Primary completion6 Mar 2024 (estimated)
  4. Study completion6 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
Non-randomized crossover controlled trial with two interventions and one sequence. The sequence of treatment is first placebo and secondly ondansetron.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514483
Sponsor's protocol ID
2023-2502
Acronym
DRIVE
Status last verified
Sep 2023
First submitted
17 Aug 2022
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ondansetron in people with Acute Respiratory Distress Syndrome, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Virginie Williams (514-338-2222 ext. 583327, virginie.williams.cnmtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure-time product of the esophageal pressure per minute (time frame: Continuous measurement during each 2-hour phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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