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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2024-05-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Non-randomized crossover controlled trial with two interventions and one sequence. The sequence of treatment is first placebo and secondly ondansetron.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Because of the single sequence of administration, blinding of study personnel would not be possible. As the primary outcome is a continuously electronically recorded physiological parameter that does not require any human interpretation, single blinding should not result in any observation bias.

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Ondansetron

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

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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NaCl 0.9% Normal Saline Sodium chloride Ondansetron hydrochloride dihydrate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No