Dexmedetomidine for Acute Respiratory Failure

(inDEX Trial)

Recruiting at 5 trial locations

Overseen By Jose Estrada

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Amphotericin B, Diazepam

Disqualifiers: Bradycardia, Hypotension, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

846 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the sedative dexmedetomidine can help patients better tolerate non-invasive ventilation (NIV) during acute respiratory failure. The researchers seek to find out if it reduces the need for invasive mechanical ventilation, where a machine assists breathing through a tube. The trial compares dexmedetomidine to a placebo, a harmless substance resembling the real treatment. Suitable participants include those experiencing discomfort, anxiety, or claustrophobia with NIV while under hospital monitoring. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking Amphotericin B or Diazepam. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that dexmedetomidine is likely to be safe for humans?

Research shows that dexmedetomidine is a sedative often used for very sick patients. Studies have found it can reduce the need for intubation (placing a tube in the throat to assist breathing) and lower the chances of delirium, which involves confusion or agitation. This suggests it is generally well-tolerated. However, one study noted a higher risk of bradycardia (a slow heart rate), a known side effect that doctors monitor.

Another study found that dexmedetomidine did not reduce the risk of respiratory failure leading to the need for a breathing machine. However, it was linked to lower death rates in patients with certain severe conditions, such as those caused by sepsis.

Since this trial is in an advanced phase, extensive safety data is already available. This suggests that dexmedetomidine is considered reasonably safe for use in people, but like any medication, it has risks that require careful management. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acute respiratory failure?

Researchers are excited about dexmedetomidine for acute respiratory failure because it offers unique benefits compared to standard sedatives like propofol or midazolam. Unlike these typical sedatives, dexmedetomidine keeps patients more wakeful while still providing sedation, thanks to its action as an α2-adrenergic agonist. This means it doesn't suppress the respiratory drive, which is crucial for patients needing mechanical ventilation. Additionally, dexmedetomidine has analgesic properties and helps reduce delirium, potentially improving overall patient outcomes during intensive care.

What evidence suggests that dexmedetomidine might be an effective treatment for acute respiratory failure?

Research shows that dexmedetomidine, which participants in this trial may receive, can help reduce the need for a breathing tube in very sick adults. One study found that dexmedetomidine lowered the chance of needing a machine for breathing by 46% compared to other calming medications or a placebo. This sedative reduces confusion and the need for breathing machines without affecting breathing itself. Additionally, dexmedetomidine is linked to lower death rates in patients with serious lung problems like ARDS, a type of lung failure. Although one study did not find it reduced the risk of breathing failure, its overall benefits make it a promising option for managing sudden breathing problems. ^{1 2 3 4 5}

Who Is on the Research Team?

Kimberley Lewis, MD

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the ICU or similar units with acute respiratory failure who are agitated or intolerant of non-invasive ventilation due to discomfort, anxiety, or claustrophobia. It's not suitable for those whose conditions might be worsened by sedatives.

Inclusion Criteria

I want to stop using NIV because it makes me uncomfortable or anxious.

My doctor thinks I can't tolerate NIV due to reasons not listed.

I am currently on a non-invasive ventilation treatment for breathing failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either dexmedetomidine or placebo to evaluate the effectiveness in reducing non-invasive ventilation failures

28 days

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of NIV failure, mortality, and intubation

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine

Trial Overview The study tests whether dexmedetomidine can help patients better tolerate non-invasive ventilation and avoid needing invasive mechanical ventilation. Participants will either receive dexmedetomidine or a placebo without knowing which one they get.

How Is the Trial Designed?

Group I: Dexmedetomidine Intervention Experimental Treatment 1 Intervention

Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in IMV that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium. Patients randomized to the experimental arm will receive dexmedetomidine. At initiation, a bolus will NOT be administered. In keeping with Health Canada Guidelines, we will start the infusion at a mid-range dose of 0.5mcg/kg/h with titration either up or down by 0.1mcg/kg/h every 20-30 minutes to a maximum rate of 1.2mcg/kg/h to maintain light sedation (RASS = -2 to +1 or SAS 3-4). Each bag will be composed of composed of dexmedetomidine 4mcg/mL(in 0.9% sodium chloride) prepared as a volume of 100mL and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans.

Group II: Placebo Control Placebo Group 1 Intervention

Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8579314/

Safety and Efficacy of Dexmedetomidine in Acutely Ill Adults ... Compared with any sedation strategy or placebo, dexmedetomidine reduced the risk of delirium and the need for mechanical ventilation while increasing the risk ...

2. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1565098/full

a propensity score-matched cohort analysis Conclusion: The results indicate an association between the administration of dexmedetomidine and lower mortality rates among severely ill ARDS patients.

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-02961-y

Dexmedetomidine for Sepsis ARDS: Reduced Mortality Study Intravenous administration of DEX was associated with reduced in-hospital mortality, at least in part, by ameliorating ABG indices and inflammatory mediators.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369221000325

Safety and Efficacy of Dexmedetomidine in Acutely Ill ... The use of dexmedetomidine, compared with other sedation strategies or placebo, reduced the risk of intubation (RR, 0.54; 95% CI, 0.41-0.71; moderate certainty) ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39552466/

A Multicentre Cohort Study Conclusion: Dexmedetomidine did not appear to lower the risk of respiratory failure necessitating invasive mechanical ventilation in critically ...