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Analgesic

IV Acetaminophen for Delirium After Heart Surgery (IVACS-Pilot Trial)

Phase 3
Recruiting
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects over 18 years of age undergoing elective aortocoronary bypass surgery, single valve replacement, or single valve and aortocoronary bypass surgery
Be older than 18 years old
Must not have
Requested late extubation by anesthesia or surgeon
Alzheimer's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

"This trial is comparing intravenous acetaminophen and oral placebo versus intravenous placebo and oral acetaminophen in patients after heart surgery. The main thing they are looking at is whether the patients

Who is the study for?
This trial is for adults over 18 who are having elective heart surgery, like bypass or valve replacement. It's not suitable for anyone else.
What is being tested?
The study tests if IV acetaminophen can prevent delirium after heart surgery compared to an oral placebo. Participants won't know which treatment they're getting in this double-blind setup.
What are the potential side effects?
Possible side effects of acetaminophen may include allergic reactions, skin rashes, and liver issues when used frequently or in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and scheduled for specific heart surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My doctor has requested a delayed removal of my breathing tube after surgery.
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I have been diagnosed with Alzheimer's disease.
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I am taking medication for memory loss.
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I have Parkinson's disease.
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I have had seizures recently.
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My kidney function is low, with a creatinine clearance under 30 ml/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~icu stay is measured from the hour of arrival in the icu and until the patient leaves the icu in hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and icu stay is measured from the hour of arrival in the icu and until the patient leaves the icu in hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Development of delirium post operatively
Secondary study objectives
Intensive care length of stay
Numeric pain rating scale
cognitive function
+2 more

Side effects data

From 2008 Phase 4 trial • 35 Patients • NCT00616018
19%
nausea
11%
headache
7%
diarrhoea
7%
fatigue
7%
migraine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acetaminophen

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous AcetaminophenExperimental Treatment1 Intervention
subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses
Group II: Oral acetaminophenActive Control1 Intervention
subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
FDA approved

Find a Location

Who is running the clinical trial?

McMaster UniversityOTHER
917 Previous Clinical Trials
2,615,344 Total Patients Enrolled
6 Trials studying Delirium
3,153 Patients Enrolled for Delirium
University of ManitobaOTHER
620 Previous Clinical Trials
205,881 Total Patients Enrolled
8 Trials studying Delirium
2,415 Patients Enrolled for Delirium
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
166,061 Total Patients Enrolled
3 Trials studying Delirium
1,566 Patients Enrolled for Delirium
~372 spots leftby Nov 2025
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