Delirium Clinical Trial
— CODEXOfficial title:
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial
NCT number | NCT04289142 |
Other study ID # | 1743 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | March 2026 |
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.
Status | Recruiting |
Enrollment | 2400 |
Est. completion date | March 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU) - Age =60 Exclusion Criteria: - Lack of patient consent - Pre-operative major cognitive dysfunction (CogState Brief Battery score < 80) - Aortic arch replacement/re-implantation (Bentalls) - Allergy/contraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR < 50 , grade 4 LV, renal failure or on renal replacement therapy) - Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month time points) |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | London Health Sciences Centre, McMaster University, University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative cognitive dysfunction | Presence of POCD assessed by CogState Brief Battery (CBB) | 3 months | |
Secondary | Post-operative cognitive dysfunction (POCD) at 1 week, 6 months, 12 months after surgery | POCD assessed by CogState Brief Battery (CBB) | 1 week, 6 and 12 months | |
Secondary | Delirium | Confusion Assessment Method (CAM/CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC), binary scale to determine if delirium is present or absent | Anytime up to post-operative day 10 | |
Secondary | Length of stay | ICU and total hospital stay | An average of 5 -14 days | |
Secondary | Depressive symptoms | Evaluated by PHQ-9 (Patient Health Questionnaire, scale 0-27, higher score is worse outcome) | 3, 6, and 12 months | |
Secondary | Persistent Surgical Site Pain | Evaluated by Brief Pain Inventory | 3, 6, and 12 months | |
Secondary | Quality of Surgical Recovery | Evaluated by QoR- (Quality of Recovery) 40 questionnaire (scale: 0-200, higher is better outcome) | 3, 6, 12 months | |
Secondary | Mild Cognitive Impairment | Presence of MCI assessed by CogState Brief Battery (CBB) | 3, 6, and 12 months | |
Secondary | In-hospital mortality for index surgery | death before hospital discharge after surgery | through initial inpatient admission, average of 1 week | |
Secondary | Opioid consumption to POD 4 | Cumulative opioid consumption | 4 days | |
Secondary | Time to extubation | Time from ICU arrival to cessation of mechanical ventilation | through ICU stay, average of 12 hours |
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