Recruiting
Phase 3

Acetaminophen

Sponsor:

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

Code:

NCT05246644

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

acetaminophen

Study Details

Brief summary:

Double blind double dummy of Intravenous Acetaminophen and oral acetaminophen placebo versus IV placebo versus oral acetaminophen in patients following cardiac surgery. The primary endpoint is development of Delirium during the post-operative stay.

Conditions

Delirium

Study ID

NCT05246644

Start date

Jun 6, 2023

Status verified date

Feb, 2024

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • subjects > 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery

Exclusion Criteria:

  • • Refusal by surgeon for inclusion of the patient

  • Requested late extubation by anesthesia or surgeon
  • Intra-aortic balloon pump
  • Sensitivity to acetaminophen
  • Pre-operative cognitive dysfunction
  • Psychiatric history with active treatment
  • Parkinson's disease
  • Alzheimer's disease
  • Medication for cognitive decline
  • History of recent seizures
  • Recent history of alcohol misuse
  • Creatinine clearance less than 30 ml/min

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intravenous Acetaminophen

subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses

active comparator: Oral acetaminophen

subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses

Interventions

acetaminophen

we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen

Primary outcome measure

  • Development of delirium post operatively [ Time Frame: up to 7 days post operatively ]

Central Contacts and Locations

Central contacts

sheldon magder, MD

5149475918sheldon.magder@mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3Y 1W9

Contacts

sheldon magder, MD

5149475918sheldon.magder@mcgill.ca

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada

Contacts

Yoan Lamarche, MD

514991-3845yoanlamarche@gmail.com

More Information

Sponsor

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

Last update posted

Feb 28, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-02-28.