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

Trial Summary

What is the purpose of this trial?

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV. The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure.

Research Team

Kimberley Lewis, MD

Principal Investigator

St. Joseph's Healthcare Hamilton

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+