Using IV Acetaminophen to Prevent Delirium After Heart Surgery
Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery
This study is testing if giving IV acetaminophen can help prevent delirium in adults after heart surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT05246644 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of intravenous acetaminophen in preventing delirium in patients undergoing cardiac surgery. It employs a randomized, double-blind, and multicenter design, enrolling patients aged 18 and older who are scheduled for aortocoronary bypass or valve surgeries. Participants will receive either IV acetaminophen or a placebo, alongside oral acetaminophen or its placebo, with the primary goal of assessing delirium development during their postoperative stay. The study will initially enroll 120 patients across four centers, with results potentially informing a larger follow-up study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective aortocoronary bypass or valve surgeries.
Not a fit: Patients with pre-existing cognitive dysfunction, psychiatric conditions, or those on medications for cognitive decline may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of delirium in patients after cardiac surgery, improving recovery outcomes.
How similar studies have performed: While similar approaches have been explored, this specific pilot study is novel in its focus on postoperative delirium prevention using IV acetaminophen.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * subjects \> 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery Exclusion Criteria: * • Refusal by surgeon for inclusion of the patient * Requested late extubation by anesthesia or surgeon * Intra-aortic balloon pump * Sensitivity to acetaminophen * Pre-operative cognitive dysfunction * Psychiatric history with active treatment * Parkinson's disease * Alzheimer's disease * Medication for cognitive decline * History of recent seizures * Recent history of alcohol misuse * Creatinine clearance less than 30 ml/min
Where this trial is running
Montreal, Quebec and 1 other locations
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: sheldon magder, MD
- Email: sheldon.magder@mcgill.ca
- Phone: 5149475918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.