Clincosm LogoSign in Get a demo

IVACS: IV Acetaminophen After Cardiac Surgery

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05246644
Collaborator
McMaster University (Other), Montreal Heart Institute (Other), University of Manitoba (Other)
900
Enrollment
2
Arms
21
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized double blind double dummyrandomized double blind double dummy
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
blinded medication with codes kept in the pharmacy
Primary Purpose:
Prevention
Official Title:
Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Development of delirium post operatively [up to 7 days 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

    Secondary Outcome Measures

    1. total opioid usage [up to 7 days post-operatively]

      tabulation of all opioids normalized to morphine

    2. Numeric pain rating scale [up to 48 hours]

      visual pain score from 1 to 10

    3. cognitive function [7 days post-operative, 6 months and 1 year]

      change in cognitive function score by 2 based on the Montreal cognitive assessment

    4. hospital length of stay [length of stay is measured from the day of surgery until the day of discharge from hospital in days]

      Days until discharge

    5. 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]

      hours in ICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • McGill University Health Centre/Research Institute of the McGill University Health Centre
    • McMaster University
    • Montreal Heart Institute
    • University of Manitoba

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheldon Magder, Senior Physician, McGill University Health Centre/Research Institute of the McGill University Health Centre
    ClinicalTrials.gov Identifier:
    NCT05246644
    Other Study ID Numbers:
    • MUHC-ACETAMINOPHEN
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Delirium
    Acetaminophen

    Study Results

    No Results Posted as of Feb 18, 2022