IV Acetaminophen After Cardiac Surgery - PILOT (IVACS-Pilot)

Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium
• Intervention / Treatment: Drug: acetaminophen

Detailed Description

The study is randomized, double-blinded, and multicentre. Enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. The intervention is blinded IV acetaminophen and blinded oral active or placebo acetaminophen . The study will start with a pilot trial of 120 patients at 4 centers- 30 at each site, 15 per group. The pilot is a vanguard. If the pilot shows appropriate compliance with the protocol, reliable blinding and appropriate enrolment, the results will not be unblinded but rolled into the full study. Stratification will be by site and age < 60 or >= 60.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: SHELDON magder, MD; Phone Number: 5149475918; Email: sheldon.magder@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Recruiting
      • Montreal Heart Institute
      • Contact: Yoan Lamarche, MD; Phone Number: 514991-3845; Email: yoanlamarche@gmail.com
    • Montreal, Quebec, Canada, H3Y 1W9
      • Recruiting
      • McGill University Health Centre
      • Contact: SHELDON magder, MD; Phone Number: 5149475918; Email: sheldon.magder@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Acetaminophen; subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses	Drug: acetaminophen; we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen; Other Names: placebo
Active Comparator: Oral acetaminophen; subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses	Drug: acetaminophen; we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total opioid usage	tabulation of all opioids normalized to morphine	up to 7 days post-operatively
Numeric pain rating scale	visual pain score from 1 to 10	up to 48 hours
cognitive function	change in cognitive function score by 2 based on the Montreal cognitive assessment	7 days post-operative, 6 months and 1 year
hospital length of stay	Days until discharge	length of stay is measured from the day of surgery until the day of discharge from hospital in days
Intensive care length of stay	hours in ICU	ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: University of Manitoba; Canadian Institutes of Health Research (CIHR); Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: MUHC-ACETAMINOPHEN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No