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Recruiting NCT06613178

Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

Phase IV Interventional Post Operative Delirium Post Operative Pain Post-Op Complication Post-cardiac Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: acetaminophen.
Who it may be relevant to
Registry conditions: Post Operative Delirium, Post Operative Pain, Post-Op Complication, Post-cardiac Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intravenous Acetaminophen After Cardiac Surgery

Overview

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 \> 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.

Interventions

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

Primary outcome measures

  • post operative delirium [Time frame: up to 7 days]
Secondary outcome measures (5)
  • total use of opioids [Time frame: up to 7 days]
  • Cognitive function at 6 months and 1 year [Time frame: 6 months and 1 year]
  • Time in intensive care unit [Time frame: up to 7 days]
  • time in hospital [Time frame: up to 7 days]
  • time to extubation [Time frame: up to 7 days]

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\'s disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Canada · 8 centers
  • University of British Columbia — Vancouver
  • University of Manitoba — Winnipeg
  • Trillium Health Centre — Mississagua
  • University of Ottawa — Ottawa
  • Sunnybroook Health Centre — Toronto
  • McGill Universtiy Health Centre — Montreal
  • Universite Montreal — Montreal
  • University of Laval — Québec

Identifiers

NCT: NCT06613178 · MUHC-ACETAMINOPHEN FULL STUDY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗