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Analgesic

Intravenous Acetaminophen for Delirium (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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours
Awards & highlights

IVACS-Pilot 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.Check my eligibility
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.See study design
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.

IVACS-Pilot Trial Eligibility Criteria

Inclusion Criteria

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

IVACS-Pilot Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Development of delirium post operatively
Secondary outcome measures
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

IVACS-Pilot 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
884 Previous Clinical Trials
2,597,416 Total Patients Enrolled
6 Trials studying Delirium
3,153 Patients Enrolled for Delirium
University of ManitobaOTHER
595 Previous Clinical Trials
198,581 Total Patients Enrolled
8 Trials studying Delirium
2,469 Patients Enrolled for Delirium
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
447 Previous Clinical Trials
158,852 Total Patients Enrolled
2 Trials studying Delirium
466 Patients Enrolled for Delirium

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals actively involved in this medical study?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this trial. The study was initially posted on June 6th, 2023 and last amended on February 25th, 2024. Recruitment aims to reach a total of 900 individuals from two distinct locations."

Answered by AI

Are participants being actively sought for this ongoing research study?

"Affirmative. The details on clinicaltrials.gov indicate that this medical study is actively seeking participants. Initially listed on June 6, 2023, and last revised on February 25, 2024, the trial aims to recruit a total of 900 patients from two distinct locations."

Answered by AI

For what purposes is IV acetaminophen typically prescribed?

"Intravenous acetaminophen has the potential to alleviate chronic pain, myalgia, and shivering."

Answered by AI

Has the FDA granted approval for intravenously administered acetaminophen?

"Based on our assessment at Power, the safety rating for Intravenous Acetaminophen is classified as a 3. This designation aligns with it being in Phase 3 of the trial, signifying existing efficacy data and substantial safety evidence."

Answered by AI

Are there any previous studies examining the use of IV Acetaminophen in a clinical setting?

"Presently, there are 26 ongoing research projects investigating the effects of Intravenous Acetaminophen. Among these studies, 7 have progressed to Phase 3 trials. Although a significant portion of the investigations are conducted in Houston, Texas, this treatment is being studied at a total of 45 diverse locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IV Acetaminophen After Cardiac Surgery - PILOT
magder sheldon 2023. "IV Acetaminophen After Cardiac Surgery - PILOT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05246644.
~300 spots leftby Sep 2024
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