Back to resultsIV Acetaminophen After Cardiac Surgery (IVACS)
Primary Purpose
Delirium
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
acetaminophen
Sponsored by
About this trial
This is an interventional prevention trial for Delirium
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravenous Acetaminophen
Oral acetaminophen
Arm Description
subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses
subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
total opioid usage
tabulation of all opioids normalized to morphine
Numeric pain rating scale
visual pain score from 1 to 10
cognitive function
change in cognitive function score by 2 based on the Montreal cognitive assessment
hospital length of stay
Days until discharge
Intensive care length of stay
hours in ICU
Full Information
NCT ID
NCT05246644
First Posted
December 15, 2021
Last Updated
February 15, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
McMaster University, Montreal Heart Institute, University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT05246644
Brief Title
IV Acetaminophen After Cardiac Surgery
Acronym
IVACS
Official Title
Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
McMaster University, Montreal Heart Institute, University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized double blind double dummy
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
blinded medication with codes kept in the pharmacy
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Acetaminophen
Arm Type
Experimental
Arm Description
subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses
Arm Title
Oral acetaminophen
Arm Type
Active Comparator
Arm Description
subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses
Intervention Type
Drug
Intervention Name(s)
acetaminophen
Other Intervention Name(s)
placebo
Intervention Description
we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen
Primary Outcome Measure Information:
Title
Development of delirium post operatively
Description
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
Time Frame
up to 7 days post operatively
Secondary Outcome Measure Information:
Title
total opioid usage
Description
tabulation of all opioids normalized to morphine
Time Frame
up to 7 days post-operatively
Title
Numeric pain rating scale
Description
visual pain score from 1 to 10
Time Frame
up to 48 hours
Title
cognitive function
Description
change in cognitive function score by 2 based on the Montreal cognitive assessment
Time Frame
7 days post-operative, 6 months and 1 year
Title
hospital length of stay
Description
Days until discharge
Time Frame
length of stay is measured from the day of surgery until the day of discharge from hospital in days
Title
Intensive care length of stay
Description
hours in ICU
Time Frame
ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
IV Acetaminophen After Cardiac Surgery
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