Actively Recruiting
Intravenous Acetaminophen After Cardiac Surgery to Prevent Delirium and Improve Recovery
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-09-25
1100
Participants Needed
8
Research Sites
23 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
L
Laval University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intravenous (IV) acetaminophen compared to oral acetaminophen to prevent delirium after cardiac surgery. The study focuses on patients aged 18 and older who are undergoing elective cardiac surgery, including aorto-coronary bypass with or without valve replacement. The goal is to see if better pain control and reduced narcotic use can lower delirium rates within the first week after surgery. Secondary outcomes include opioid use, length of ICU and hospital stays, and cognitive function at 6 months and 1 year post-surgery. Participants will be randomly assigned to receive either IV acetaminophen with an oral placebo or placebo IV fluid with oral acetaminophen every 6 hours for 48 hours after surgery. This double-blind study is conducted at eight Canadian cardiac surgery centers, with all other treatments following standard hospital protocols. The study also monitors the use of NSAIDs, such as ketorolac, and any related complications. During the study, patients will be assessed daily for delirium up to 7 days post-surgery using the Confusion Assessment Method in the ICU and on the regular floors. Pain levels, opioid use, time to extubation, and lengths of ICU and hospital stays will be recorded. Cognitive function will be measured before surgery and again at 6 months and 1 year using the Montreal Cognitive Assessment. Safety and complications related to NSAID use will also be tracked throughout the trial period, which continues until December 2027.
CONDITIONS
Brief Title
Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for elective cardiac surgery
- Stable condition before surgery
- Undergoing aorto-coronary bypass with or without valve replacement
You will not qualify if you...
- Surgeon refusal to participate
- Requested delayed extubation by surgeon or anesthesia
- Use of intra-aortic balloon pump or mechanical cardiac support
- Sensitivity or allergy to acetaminophen
- Current active psychiatric treatment
- Alzheimer's disease diagnosis
- Seizure within the previous 6 months
- Recent history of alcohol misuse
- Cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours after surgery
Participants undergo elective cardiac surgery and receive either intravenous acetaminophen with oral placebo or placebo intravenous fluid with oral acetaminophen every 6 hours for 48 hours after surgery. All other treatments follow standard care protocols.
1 hospital stay including intensive care unit monitoring up to 7 days
Duration - Up to 1 year
Participants are assessed for post-operative delirium, opioid use, cognitive function, pain scores, and recovery outcomes up to 1 year after surgery.
Assessments at 6 months and 1 year; daily assessments up to 7 days post-surgery during hospital stay
Trial Site Locations
Total: 8 locations
1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
Active, Not Recruiting
2
University of Manitoba
Winnipeg, Manitoba, Canada, R3T2N2
Actively Recruiting
3
Trillium Health Centre
Mississagua, Ontario, Canada, L5B2V2
Not Yet Recruiting
4
University of Ottawa
Ottawa, Ontario, Canada, K1N6N5
Not Yet Recruiting
5
Sunnybroook Health Centre
Toronto, Ontario, Canada, M4N3M5
Not Yet Recruiting
6
McGill Universtiy Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
7
Universite Montreal
Montreal, Quebec, Canada, R3T2N2
Actively Recruiting
8
University of Laval
Québec, Quebec, Canada, G1V0A6
Actively Recruiting
Research Team
S
Sheldon Magder, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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