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5-HT3 Receptor Antagonist and Respiratory Drive in Patients With ARDS | Clinical Trials | Clareo Health

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5-HT3 Receptor Antagonist and Respiratory Drive 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

NCT05514483•Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Key Dates

Start Date

November 10, 2022

Primary Completion Date

March 6, 2024

Completion Date

May 6, 2024

Last Updated

September 28, 2023

Enrollment

ESTIMATED participants

Conditions

Acute Respiratory Distress Syndrome

Interventions

Placebo

DRUG

Ondansetron

DRUG

Contacts

Virginie Williams

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

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