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NCT Number: NCT06613178

Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Acetaminophen

Drug

Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded

Other names: placebo

Primary outcomes

  1. post operative delirium

    Time frame: up to 7 days

    measured with CAMICU or CAM

Secondary outcomes

  1. total use of opioids

    Time frame: up to 7 days

    measured for 7 days or until hospital discharge

  2. Cognitive function at 6 months and 1 year

    Time frame: 6 months and 1 year

    Measured with Montreal Cognitive assessment score.

  3. Time in intensive care unit

    Time frame: up to 7 days

    measured in hours

  4. time in hospital

    Time frame: up to 7 days

    measured in days

  5. time to extubation

    Time frame: up to 7 days

    measured in hours

Study contacts

Contact information is provided by the study sponsor or research team.

Sheldon Magder, MD

CONTACT

[email protected]

5149475918

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Laval University
  • St. Boniface Hospital
  • Sunnybrook Health Sciences Centre
  • Trillium Health Centre
  • University of British Columbia
  • University of Ottawa
  • Université de Montréal

Registry information

Official study title

Intravenous Acetaminophen After Cardiac Surgery

Acronym: IVACS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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