DeliriumPhase 3IVACS-PilotNCT05246644
IV Acetaminophen After Cardiac Surgery - PILOT
A Phase 3 study testing acetaminophen in people with Delirium, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Jun 2023to 15 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects > 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery
Who cannot join
- • 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3Y 1W9
sheldon magder, MD, 5149475918, sheldon.magder@mcgill.ca
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Yoan Lamarche, MD, 514991-3845, yoanlamarche@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Delirium
- Being tested
- acetaminophen
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
Also called placebo
we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Acetaminophen | Experimental | subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses Receives: 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 Receives: Drug: acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 7 days post operatively
Secondary outcomes (5)
total opioid usage
tabulation of all opioids normalized to morphine
Measured: up to 7 days post-operatively
Numeric pain rating scale
visual pain score from 1 to 10
Measured: up to 48 hours
cognitive function
change in cognitive function score by 2 based on the Montreal cognitive assessment
Measured: 7 days post-operative, 6 months and 1 year
hospital length of stay
Days until discharge
Measured: 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
Measured: ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start6 Jun 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blind double dummy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Heart Institute, University of Manitoba, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, magder sheldon, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246644
- Sponsor's protocol ID
- MUHC-ACETAMINOPHEN
- Acronym
- IVACS-Pilot
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05246644
- Acronym / sponsor ID
- IVACS-Pilot / MUHC-ACETAMINOPHEN
- Conditions
- Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Montreal Heart Institute, University of Manitoba, Canadian Institutes of Health Research (CIHR)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind double dummy
| Arm | Type | Receives |
|---|---|---|
| Intravenous Acetaminophen | Experimental | Drug: acetaminophensubjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses |
| Oral acetaminophen | Active comparator | Drug: acetaminophensubjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects > 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery
Key exclusion criteria (12 listed)
- • Refusal by surgeon for inclusion of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophenAlso: placebowe will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen | Drug | Intravenous Acetaminophen, Oral acetaminophen |
Primary outcome
Development of delirium post operatively
Time frame: 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
5 secondary outcomes
total opioid usage
Time frame: up to 7 days post-operatively
Numeric pain rating scale
Time frame: up to 48 hours
cognitive function
Time frame: 7 days post-operative, 6 months and 1 year
hospital length of stay
Time frame: length of stay is measured from the day of surgery until the day of discharge from hospital in days
Intensive care length of stay
Time frame: ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetaminophen in people with Delirium, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sheldon magder, MD (5149475918, sheldon.magder@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of delirium post operatively (time frame: up to 7 days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.