Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

Last updated: September 23, 2024
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

acetaminophen

Clinical Study ID

NCT06613178
MUHC-ACETAMINOPHEN FULL STUDY
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

greater or equal to 18

  • elective cardiac surgery

  • stable pre-operative

  • aorto-coronary bypass with or without 1 valve replacement.

Exclusion

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

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: acetaminophen
Phase: 4
Study Start date:
July 02, 2024
Estimated Completion Date:
December 15, 2027

Study Description

Patients > 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.

Connect with a study center

  • University of British Columbia

    Vancouver, British Columbia V6T 1Z4
    Canada

    Site Not Available

  • University of Manitoba

    Winnipeg, Manitoba R3T2N2
    Canada

    Active - Recruiting

  • Trillium Health Centre

    Mississagua, Ontario L5B2V2
    Canada

    Site Not Available

  • University of Ottawa

    Ottawa, Ontario K1N6N5
    Canada

    Site Not Available

  • Sunnybroook Health Centre

    Toronto, Ontario M4N3M5
    Canada

    Site Not Available

  • McGill Universtiy Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Universite Montreal

    Montreal, Quebec R3T2N2
    Canada

    Active - Recruiting

  • University of Laval

    Quebec City, Quebec G1V0A6
    Canada

    Active - Recruiting

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