Using intravenous acetaminophen to prevent delirium after heart surgery
Official title: Intravenous Acetaminophen After Cardiac Surgery
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06613178 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1100 (estimated) |
| 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) |
| Status | Recruiting |
| Started | July 2, 2024 |
| Main results expected | July 1, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | September 25, 2024 |
| Trial ID | NCT06613178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older scheduled for elective cardiac surgery, specifically aorto-coronary bypass with or without valve replacement.
✕Probably not a fit
Patients with a history of psychiatric treatment, cognitive impairment, or sensitivity to acetaminophen may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with similar approaches in pain management and delirium prevention, suggesting potential for success.
Who can join: the full rules
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 it's running
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University of Manitoba
Winnipeg, Manitoba, Canada Recruiting -
McGill Universtiy Health Centre
Montreal, Quebec, Canada Recruiting -
Universite Montreal
Montreal, Quebec, Canada Recruiting -
University of Laval
Québec, Quebec, Canada Recruiting -
University of British Columbia
Vancouver, British Columbia, Canada Active not recruiting -
Trillium Health Centre
Mississagua, Ontario, Canada Not yet recruiting
Show 2 more locations
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University of Ottawa
Ottawa, Ontario, Canada Not yet recruiting -
Sunnybroook Health Centre
Toronto, Ontario, Canada Not yet recruiting
Study contacts
- Study coordinator: Sheldon Magder, MD
- Email: sheldon.magder@mcgill.ca
- Phone: 5149475918
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.