Recruiting

5-HT3 Antagonist

Sponsor:

Hopital du Sacre-Coeur de Montreal

Code:

NCT05514483

Conditions

Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Ondansetron

Study Details

Brief 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). 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.

Conditions

Acute Respiratory Distress Syndrome

Study ID

NCT05514483

Start date

Nov 10, 2022

Status verified date

Sep, 2023

Completion date

May 6, 2024

Anticipated

Primary completion date

Mar 6, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

All participants will receive a single injection of placebo, followed, three hours later, by a single injection of ondansetron.

active comparator: Ondansetron

All participants will receive a single injection of placebo, followed, three hours later, by a single injection of ondansetron.

Interventions

Placebo

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

Ondansetron

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

Primary outcome measure

  • Pressure-time product of the esophageal pressure per minute [ Time Frame: Continuous measurement during each 2-hour phase ]

Central Contacts and Locations

Central contacts

Virginie Williams

514-338-2222virginie.williams.cnmtl@ssss.gouv.qc.ca

Locations

Hôpital Sacré-Coeur de Montréal

Recruiting

Montréal, Quebec, Canada, H4J1C5

Contacts

Virginie Williams, PhD

514-338-2222virginie.williams.cnmtl@ssss.gouv.qc.ca

Principal Investigator:

Yiorgos Alexandros Cavayas, MD MSc FRCPC

More Information

Sponsor

Hopital du Sacre-Coeur de Montreal

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Keywords

  • ARDS
  • Ondansetron

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hopital du Sacre-Coeur de Montreal on 2023-09-28.