Clinical trial NCT06613178: Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
Official title: Intravenous Acetaminophen After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post Operative Delirium
Post Operative Pain
Post-Op Complication
Post-cardiac Surgery
Keywords: pain
post-operative care
cardiac surgery
narcotic
acetaminophen
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Laval University
name: University of British Columbia
name: St. Boniface Hospital
name: University of Ottawa
name: Trillium Health Centre
name: Université de Montréal
name: Sunnybrook Health Sciences Centre
First posted: 2024-09-25
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind double dummy two arm study
Primary purpose: PREVENTION

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.

Detailed description: Patients \&gt; or equal to 18 years of going for elective cardiac surgery will be randomized to receive IV either IV acetaminophen and an oral placebo acetaminophen or an IV placebo acetaminophen (saline) and oral acetaminophen every 6 hours for 48 hours after cardiac surgery. the study will be performed at 8 large Canadian cardiac surgery centres. All other therapy will be as per standard procedures (pragmatic) at the institutions including including use of their standard opioid protocol. The primary end-point is the development of delirium as assessed by Confusion Assessment Method in the Intensive Care unit (CAMICU) and the CAM on the regular floor unit for up to 7 days after surgery or discharge if it is sooner. Other measures are change from pre-operative cognitive function as assessed by the Montreal Cognitive Assessment score (MoCA) at 6 months and 1 year, numeric pain score, total opioid use, hospital and ICU length of stay. Use of opioids and pain score at 1 year also will be assessed. Patients will be stratified by site and sex.

We also will assess use of NSAID, specifically ketorolac, and any NSAID associated events.

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\&#39;s disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment

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Primary outcomes:
measure: post operative delirium
timeFrame: up to 7 days
Secondary outcomes:
measure: total use of opioids
timeFrame: up to 7 days
measure: Cognitive function at 6 months and 1 year
timeFrame: 6 months and 1 year
measure: Time in intensive care unit
timeFrame: up to 7 days
measure: time in hospital
timeFrame: up to 7 days
measure: time to extubation
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Mississagua
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Sunnybroook Health Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill Universtiy Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Universite Montreal
state: Quebec
city: Quebec City
country: Canada
facility: University of Laval
state: Quebec
Study officials:
References: