Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial

Who is this study for? Adult patients with postoperative cognitive dysfunction
What treatments are being studied? Dexmedetomidine
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)

• Age ≥60

Locations
Other Locations
Canada
London Health Sciences
RECRUITING
London
University of Saskatchewan
RECRUITING
Saskatoon
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Toronto General Hospital
RECRUITING
Toronto
Royal Columbian Hospital
RECRUITING
Vancouver
St. Paul's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Stephen Choi, MD,MSc,FRCPC
stephen.choi@sunnybrook.ca
416-480-6100
Backup
Lilia Kaustov, PhD
lilia.kaustov@sunnybrook.ca
416-480-6100
Time Frame
Start Date: 2019-12-01
Estimated Completion Date: 2029-03
Participants
Target number of participants: 2400
Treatments
Active_comparator: Dexmedetomidine Hydrochloride Group
Patients will receive a loading dose of 1.2 μg/kg dexmedetomidine prior to transfer to CVICU over 20-60 min immediately postoperative, followed by continuous infusion of 0.3 μg/kg/h for up to 12 hours or until patient is ready for discharge from CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.
No_intervention: Standard of Care Group
Standard sedation protocols will be followed at the discretion of the attending physician.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Alzheimer's Association, Providence Health & Services, Hamilton Health Sciences Corporation, University Health Network, Toronto, The Dana Foundation, London Health Sciences Centre, Fraser Health, McMaster University, Brain Canada, University of Saskatchewan
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov