Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

NCT ID: NCT06613178

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2027-12-15

Brief Summary

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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

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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.

Conditions

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Post Operative Delirium Post Operative Pain Post-Op Complication Post-cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized double blind double dummy two arm study
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple. blinded medication with codes kept by pharmacy director

Study Groups

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Oral Placebo

Subject receives active intravenous acetaminophen and oral placebo acetaminophen

Group Type ACTIVE_COMPARATOR

acetaminophen

Intervention Type DRUG

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

Oral Acetaminophen

Subject receives placebo IV fluid (saline) and active oral acetaminophen

Group Type PLACEBO_COMPARATOR

acetaminophen

Intervention Type DRUG

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

Interventions

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acetaminophen

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

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role collaborator

University of Ottawa

OTHER

Sponsor Role collaborator

Trillium Health Centre

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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magder sheldon

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status ACTIVE_NOT_RECRUITING

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Trillium Health Centre

Mississagua, Ontario, Canada

Site Status NOT_YET_RECRUITING

University of Ottawa

Ottawa, Ontario, Canada

Site Status NOT_YET_RECRUITING

Sunnybroook Health Centre

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

McGill Universtiy Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Universite Montreal

Montreal, Quebec, Canada

Site Status RECRUITING

University of Laval

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sheldon Magder, MD

Role: CONTACT

5149475918

Facility Contacts

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Rakesh Arora, MD PhD

Role: primary

2165082112

Bill Wong, MD

Role: primary

905-848-7178

Bernard McDonald, MD MSc

Role: primary

613-612-5412

Neill Adhikari, MD MSc

Role: primary

416-480-4522

SHELDON magder, MD

Role: primary

5149475918

Rayhaneh Rahgoshai, BA

Role: backup

5149341934

Yoan Lamarche, MD, PhD

Role: primary

514 991-3845

Siamak Mohammadi, MD

Role: primary

1 418-656-4717

Other Identifiers

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MUHC-ACETAMINOPHEN FULL STUDY

Identifier Type: -

Identifier Source: org_study_id

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