IV Acetaminophen After Cardiac Surgery - PILOT

NCT05246644 | Recruiting Phase 3

• 1 other identifier: MUHC-ACETAMINOPHEN
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Development of delirium post operatively

  Incidence of delirium will be analyzed between patients treated with IV or oral acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM) or CAMICU when in the intensive care unit

  up to 7 days post operatively

Secondary Outcomes (5)

• total opioid usage

  up to 7 days post-operatively

• Numeric pain rating scale

  up to 48 hours

• cognitive function

  7 days post-operative, 6 months and 1 year

• hospital length of stay

  length of stay is measured from the day of surgery until the day of discharge from hospital in days

• Intensive care length of stay

  ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours

Study Arms (2)

Intravenous Acetaminophen

EXPERIMENTAL

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

Drug: acetaminophen

Oral acetaminophen

ACTIVE COMPARATOR

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

Drug: acetaminophen

Interventions

acetaminophen DRUG

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

Also known as: placebo

Intravenous Acetaminophen; Oral acetaminophen

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Montreal Heart Institute: collaborator
• University of Manitoba: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

McGill University Health Centre

Montreal, Quebec, H3Y 1W9, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, 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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinded medication with codes kept in the pharmacy
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Model Details: randomized double blind double dummy

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 18, 2022
• Study Start: June 6, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 15, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CA (2)