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Alpha-2 Adrenergic Agonist
Dexmedetomidine for Postoperative Cognitive Dysfunction (CODEX Trial)
Phase 4
Recruiting
Led By Stephen Choi, MD,MSc,FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)
Age ≥60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months
Awards & highlights
CODEX Trial Summary
This trial is testing whether the drug Dexmedetomidine can prevent postoperative cognitive dysfunction (POCD), which is when patients have trouble thinking and remembering after surgery.
Who is the study for?
This trial is for cardiac surgery patients aged 60 or older who are recovering in the CVICU and can complete cognitive tests post-surgery. It's not for those with major pre-op cognitive issues, certain heart conditions, severe liver or kidney disease, or an allergy to dexmedetomidine.Check my eligibility
What is being tested?
The study is testing whether Dexmedetomidine (DEX) can prevent long-term memory and thinking problems after cardiac surgery. The goal is to see if DEX improves recovery and reduces hospital stay and healthcare costs.See study design
What are the potential side effects?
Possible side effects of Dexmedetomidine may include slow heart rate, low blood pressure, dry mouth, nausea. In rare cases it might cause serious allergic reactions.
CODEX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for heart surgery that requires opening my chest, with initial recovery in the CVICU.
Select...
I am 60 years old or older.
CODEX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative cognitive dysfunction
Secondary outcome measures
Delirium
Depressive symptoms
In-hospital mortality for index surgery
+7 moreCODEX Trial Design
2Treatment groups
Active Control
Group I: Dexmedetomidine Hydrochloride GroupActive Control1 Intervention
Patients will receive a loading dose of 1.2 μg/kg dexmedetomidine prior to transfer to CVICU over 20 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.
Group II: Standard of Care GroupActive Control1 Intervention
Standard sedation protocols will be followed at the discretion of the attending physician.
Find a Location
Who is running the clinical trial?
London Health Sciences CentreOTHER
143 Previous Clinical Trials
47,562 Total Patients Enrolled
Sunnybrook Health Sciences CentreLead Sponsor
659 Previous Clinical Trials
1,551,113 Total Patients Enrolled
McMaster UniversityOTHER
893 Previous Clinical Trials
2,607,502 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe allergies or conditions that dexmedetomidine could worsen.I have had an aortic arch replacement or Bentall procedure.I can attend all required study visits and complete tests.I am scheduled for heart surgery that requires opening my chest, with initial recovery in the CVICU.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Dexmedetomidine Hydrochloride Group
- Group 2: Standard of Care Group
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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