Post Operative DeliriumPhase 4IVACSNCT06613178
Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
A Phase 4 study testing acetaminophen in people with Post Operative Delirium and Post Operative Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 sites in Canada.
Trial summary
Double blind, double dummy trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Delirium, Post Operative Pain, Post-Op Complication
- What is being tested?
- acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 8 sitesCanada
- Study dates
- 2 Jul 2024to 15 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- greater or equal to 18
- elective cardiac surgery
- stable pre-operative
- aorto-coronary bypass with or without 1 valve replacement.
Who cannot join
- Refusal by surgeon Requested late extubation by surgeon or anesthesia Intra-aortic balloon pump Mechanical cardiac support Sensitivity to acetaminophen Psychiatric history with current active treatment Alzheimer\'s disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment
- -
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Canada8 sites, 7 recruiting
- Not yet recruiting
Trillium Health Centre
Mississagua, Ontario, L5B2V2
Bill Wong, MD, 905-848-7178, bill.wong@thp.ca
- Recruiting
McGill Universtiy Health Centre
Montreal, Quebec, H4A 3J1
SHELDON magder, MD, 5149475918, sheldon.magder@mcgill.ca
Rayhaneh Rahgoshai, BA, 5149341934
- Recruiting
Universite Montreal
Montreal, Quebec, R3T2N2
Yoan Lamarche, MD, PhD, 514 991-3845, yoanlamarche@gmail.com
- Not yet recruiting
University of Ottawa
Ottawa, Ontario, K1N6N5
Bernard McDonald, MD MSc, 613-612-5412, Bbmcdonald@ottawaheart.ca
- Recruiting
University of Laval
Québec, Quebec, G1V0A6
Siamak Mohammadi, MD, 1 418-656-4717, siamak.mohammadi@fmed.ulaval.ca
- Not yet recruiting
Sunnybroook Health Centre
Toronto, Ontario, M4N3M5
Neill Adhikari, MD MSc, 416-480-4522, neill.adhikari@sunnybrook.ca
- Active, not recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3T2N2
Rakesh Arora, MD PhD, 2165082112, rakesh.arora@uhhospitals.org
About this study
Official title: Intravenous Acetaminophen After Cardiac Surgery
Double blind, double dummy trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. Other important secondary outcomes are the total use of narcotics, ICU and hospital stay, improved cognitive function at 6 months and 1 year post surgery, NSAID use at each centre and associated NSAID complications.
Read the detailed description
Patients \> or equal to 18 years of going for elective cardiac surgery will be randomized to receive IV either IV acetaminophen and an oral placebo acetaminophen or an IV placebo acetaminophen (saline) and oral acetaminophen every 6 hours for 48 hours after cardiac surgery. the study will be performed at 8 large Canadian cardiac surgery centres. All other therapy will be as per standard procedures (pragmatic) at the institutions including including use of their standard opioid protocol. The primary end-point is the development of delirium as assessed by Confusion Assessment Method in the Intensive Care unit (CAMICU) and the CAM on the regular floor unit for up to 7 days after surgery or discharge if it is sooner. Other measures are change from pre-operative cognitive function as assessed by the Montreal Cognitive Assessment score (MoCA) at 6 months and 1 year, numeric pain score, total opioid use, hospital and ICU length of stay. Use of opioids and pain score at 1 year also will be assessed. Patients will be stratified by site and sex.
We also will assess use of NSAID, specifically ketorolac, and any NSAID associated events.
- Being tested
- acetaminophen
- Keywords
- pain, post-operative care, cardiac surgery, narcotic, acetaminophen
- Medical subject headings
- Emergence Delirium, Pain, Postoperative, Postoperative Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
Also called placebo
Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded
| Study group | Role | What they receive |
|---|---|---|
| Oral Placebo | Active comparator | Subject receives active intravenous acetaminophen and oral placebo acetaminophen Receives: Drug: acetaminophen |
| Oral Acetaminophen | Placebo comparator | Subject receives placebo IV fluid (saline) and active oral acetaminophen Receives: Drug: acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative delirium
measured with CAMICU or CAM
Measured: up to 7 days
Secondary outcomes (5)
total use of opioids
measured for 7 days or until hospital discharge
Measured: up to 7 days
Cognitive function at 6 months and 1 year
Measured with Montreal Cognitive assessment score.
Measured: 6 months and 1 year
Time in intensive care unit
measured in hours
Measured: up to 7 days
time in hospital
measured in days
Measured: up to 7 days
time to extubation
measured in hours
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start2 Jul 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative DeliriumStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blind double dummy two arm study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 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
- Laval University, University of British Columbia, St. Boniface Hospital, University of Ottawa, Trillium Health Centre, Université de Montréal, Sunnybrook Health Sciences Centre
- 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
- NCT06613178
- Sponsor's protocol ID
- MUHC-ACETAMINOPHEN FULL STUDY
- Acronym
- IVACS
- Status last verified
- Jul 2024
- First submitted
- 1 Mar 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If the investigators of PANDORA complete their study we would request to combine our studies in a meta-analysis
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Acetaminophen After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06613178
- Acronym / sponsor ID
- IVACS / MUHC-ACETAMINOPHEN FULL STUDY
- Keywords
- pain, post-operative care, cardiac surgery, narcotic, acetaminophen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Laval University, University of British Columbia, St. Boniface Hospital, University of Ottawa, Trillium Health Centre, Université de Montréal, Sunnybrook Health Sciences Centre
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 25 Sep 2024 (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 trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. Other important secondary outcomes are the total use of narcotics, ICU and hospital stay, improved cognitive function at 6 months and 1 year post surgery, NSAID use at each centre and associated NSAID complications.
Detailed description
Patients \> or equal to 18 years of going for elective cardiac surgery will be randomized to receive IV either IV acetaminophen and an oral placebo acetaminophen or an IV placebo acetaminophen (saline) and oral acetaminophen every 6 hours for 48 hours after cardiac surgery. the study will be performed at 8 large Canadian cardiac surgery centres. All other therapy will be as per standard procedures (pragmatic) at the institutions including including use of their standard opioid protocol. The primary end-point is the development of delirium as assessed by Confusion Assessment Method in the Intensive Care unit (CAMICU) and the CAM on the regular floor unit for up to 7 days after surgery or discharge if it is sooner. Other measures are change from pre-operative cognitive function as assessed by the Montreal Cognitive Assessment score (MoCA) at 6 months and 1 year, numeric pain score, total opioid use, hospital and ICU length of stay. Use of opioids and pain score at 1 year also will be assessed. Patients will be stratified by site and sex.
We also will assess use of NSAID, specifically ketorolac, and any NSAID associated events.
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 two arm study
| Arm | Type | Receives |
|---|---|---|
| Oral Placebo | Active comparator | Drug: acetaminophenSubject receives active intravenous acetaminophen and oral placebo acetaminophen |
| Oral Acetaminophen | Placebo comparator | Drug: acetaminophenSubject receives placebo IV fluid (saline) and active oral acetaminophen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- greater or equal to 18
- elective cardiac surgery
- stable pre-operative
- aorto-coronary bypass with or without 1 valve replacement.
Key exclusion criteria (2 listed)
- Refusal by surgeon Requested late extubation by surgeon or anesthesia Intra-aortic balloon pump Mechanical cardiac support Sensitivity to acetaminophen Psychiatric history with current active treatment Alzheimer\'s disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment
- -
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: placeboPatient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded | Drug | Oral Acetaminophen, Oral Placebo |
Primary outcome
post operative delirium
Time frame: up to 7 days
measured with CAMICU or CAM
5 secondary outcomes
total use of opioids
Time frame: up to 7 days
Cognitive function at 6 months and 1 year
Time frame: 6 months and 1 year
Time in intensive care unit
Time frame: up to 7 days
time in hospital
Time frame: up to 7 days
time to extubation
Time frame: up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No. If the investigators of PANDORA complete their study we would request to combine our studies in a meta-analysis
Related trials for Post Operative Delirium
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Post Operative Cognitive Dysfunction After Oncologic Surgery
Emergence Delirium, Post-Operative Cognitive Dysfunction
RecruitingObservational study
The Effect of Exercise-Induced Irisin on Brain Function and Postoperative Delirium in Older Adults
Post Operative Delirium
Enrolling by invitationObservational study
Eye Movements to Predict Post-Operative Delirium
Post Operative Delerium, Post Operative Cognitive Dysfunction
Recruiting
Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
Post Operative Delirium, Cognitive Impairment
Active, not recruitingObservational study
Depth of Anaesthesia and Long-term Survival: The Balanced Anaesthesia Follow-up Study
Post-Operative Confusion, Long Term Adverse Effects
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen in people with Post Operative Delirium and Post Operative Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
post operative delirium (time frame: up to 7 days). 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 25 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.