Recruiting PHASE4 Delirium

New treatment option for Delirium

Official title Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

ClinicalTrials.gov ID: NCT04289142

What this study is testing

What is Dexmedetomidine Hydrochloride Group?

Dexmedetomidine Hydrochloride Group is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for delirium.

Also referred to as Dexmedetomidine Hydrochloride.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 60 and older

You may be able to join if

  • Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive...
  • Age ≥60

You likely can't join if

  • Lack of patient consent
  • Pre-operative major cognitive dysfunction (CogState Brief Battery score \< 80) at screening
  • Aortic arch replacement/re-implantation (surgery requiring hypothermic circulatory arrest, e.g. Bentall procedure)
  • Allergy/contraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR \< 50 , grade 4 LV...
  • Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month time points)

The study team makes the final eligibility decision.

Where it's taking place

  • Vancouver, British Columbia, Canada
  • London, Ontario, Canada
  • Toronto, Ontario, Canada
  • Québec, Quebec, Canada
  • Saskatoon, Saskatchewan, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Vancouver, British Columbia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Québec, Quebec, Canada; Saskatoon, Saskatchewan, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.