NCT06613178 Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
| NCT ID | NCT06613178 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Post Operative Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,100 participants in total. It began in 2024-07-02 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Double blind, double dummy trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. Other important secondary outcomes are the total use of narcotics, ICU and hospital stay, improved cognitive function at 6 months and 1 year post surgery, NSAID use at each centre and associated NSAID complications.
Eligibility 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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06613178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Operative Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06613178 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06613178 currently recruiting?
Yes, NCT06613178 is actively recruiting participants. Contact the research team at sheldon.magder@mcgill.ca for enrollment information.
Where is the NCT06613178 trial being conducted?
This trial is being conducted at Vancouver, Canada, Winnipeg, Canada, Mississagua, Canada, Ottawa, Canada and 4 additional locations.
Who is sponsoring the NCT06613178 clinical trial?
NCT06613178 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 1,100 participants.