Using intravenous acetaminophen to prevent delirium after heart surgery
Intravenous Acetaminophen After Cardiac Surgery
This study is testing if giving acetaminophen through an IV can help prevent delirium in adults after heart surgery compared to taking it by mouth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 8 sites (Vancouver, British Columbia and 7 other locations) |
| Trial ID | NCT06613178 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intravenous acetaminophen compared to oral acetaminophen in preventing delirium in patients undergoing elective cardiac surgery. Patients aged 18 and older will be randomly assigned to receive either IV acetaminophen with an oral placebo or oral acetaminophen with an IV placebo for 48 hours post-surgery. The primary outcome is the incidence of delirium assessed in the ICU and on the regular floor, while secondary outcomes include opioid use, length of ICU and hospital stay, and cognitive function at 6 months and 1 year. The trial will be conducted at eight major cardiac surgery centers across Canada.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective cardiac surgery, specifically aorto-coronary bypass with or without valve replacement.
Not a fit: Patients with a history of psychiatric treatment, cognitive impairment, or sensitivity to acetaminophen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced incidence of delirium in patients after cardiac surgery.
How similar studies have performed: Previous studies have shown promising results with similar approaches in pain management and delirium prevention, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: greater or equal to 18 * elective cardiac surgery * stable pre-operative * aorto-coronary bypass with or without 1 valve replacement. Exclusion Criteria: Refusal by surgeon Requested late extubation by surgeon or anesthesia Intra-aortic balloon pump Mechanical cardiac support Sensitivity to acetaminophen Psychiatric history with current active treatment Alzheimer\'s disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment \-
Where this trial is running
Vancouver, British Columbia and 7 other locations
- University of British Columbia — Vancouver, British Columbia, Canada (Active_not_recruiting)
- University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- Trillium Health Centre — Mississagua, Ontario, Canada (Not_yet_recruiting)
- University of Ottawa — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Sunnybroook Health Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
- McGill Universtiy Health Centre — Montreal, Quebec, Canada (Recruiting)
- Universite Montreal — Montreal, Quebec, Canada (Recruiting)
- University of Laval — Québec, 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.