Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

NCT06613178 | Recruiting Phase 4 DMC

• 1 other identifier: MUHC-ACETAMINOPHEN FULL STUDY
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Keywords

pain; post-operative care; cardiac surgery; narcotic; acetaminophen

Outcome Measures

Primary Outcomes (1)

• post operative delirium

  measured with CAMICU or CAM

  up to 7 days

Secondary Outcomes (5)

• total use of opioids

  up to 7 days

• Cognitive function at 6 months and 1 year

  6 months and 1 year

• Time in intensive care unit

  up to 7 days

• time in hospital

  up to 7 days

• time to extubation

  up to 7 days

Study Arms (2)

Oral Placebo

ACTIVE COMPARATOR

Subject receives active intravenous acetaminophen and oral placebo acetaminophen

Drug: acetaminophen

Oral Acetaminophen

PLACEBO COMPARATOR

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

Drug: acetaminophen

Interventions

acetaminophen DRUG

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

Also known as: placebo

Oral Acetaminophen; Oral Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• greater or equal to 18
• elective cardiac surgery
• stable pre-operative
• aorto-coronary bypass with or without 1 valve replacement.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Laval University: collaborator
• University of British Columbia: collaborator
• St. Boniface Hospital: collaborator
• University of Ottawa: collaborator
• Trillium Health Centre: collaborator
• Université de Montréal: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (8)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

ACTIVE NOT RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3T2N2, Canada

RECRUITING

Trillium Health Centre

Mississagua, Ontario, L5B2V2, Canada

NOT YET RECRUITING

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

NOT YET RECRUITING

Sunnybroook Health Centre

Toronto, Ontario, M4N3M5, Canada

NOT YET RECRUITING

McGill Universtiy Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Universite Montreal

Montreal, Quebec, R3T2N2, Canada

RECRUITING

University of Laval

Québec, Quebec, G1V0A6, Canada

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative; Postoperative Complications; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Sheldon Magder, MD

CONTACT

5149475918; sheldon.magder@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple. blinded medication with codes kept by pharmacy director
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: randomized double blind double dummy two arm study

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: September 25, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)