Status:
RECRUITING
IV Acetaminophen After Cardiac Surgery - PILOT
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Montreal Heart Institute
University of Manitoba
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Double blind double dummy of Intravenous Acetaminophen and oral acetaminophen placebo versus IV placebo versus oral acetaminophen in patients following cardiac surgery. The primary endpoint is develop...
Detailed Description
The study is randomized, double-blinded, and multicentre. Enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. The i...
Eligibility Criteria
Inclusion
- subjects \> 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery
Exclusion
- • 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
Key Trial Info
Start Date :
June 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT05246644
Start Date
June 6 2023
End Date
December 15 2024
Last Update
February 28 2024
Active Locations (2)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H3Y 1W9
2
Montreal Heart Institute
Montreal, Quebec, Canada