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Temperature Management for Postoperative Cognitive Dysfunction

Phase 2
Waitlist Available
Led By Vishal Yajnik, MD, MS
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
scheduled coronary artery bypass graft surgery patients, with or without valve surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours post surgery
Awards & highlights

Study Summary

This trial will investigate whether active temperature management can reduce postoperative cognitive dysfunction in patients following coronary artery bypass surgery.

Who is the study for?
This trial is for patients scheduled for coronary artery bypass graft surgery, with or without valve surgery, who can consent. It excludes prisoners, those under 20 or over 89 years old, emergency surgery cases, individuals with chest/thigh deformities or skin conditions affecting wrap placement, those with post-op fever ≥38.3°C, pregnant women, and patients with symptomatic cerebrovascular disease.Check my eligibility
What is being tested?
The study tests if active temperature management using Hyper/Hypothermia Wraps and Acetaminophen after cardiac surgery reduces cognitive dysfunction compared to just Acetaminophen. Participants will be divided into groups to compare the effectiveness of combined treatment versus acetaminophen alone.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the wraps and typical risks associated with acetaminophen use such as allergic reactions or liver damage when not used as directed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery to improve blood flow to my heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cognitive Function post CABG
Secondary outcome measures
Variability in Temperature

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Tylenol with body wrapExperimental Treatment2 Interventions
This group will receive the standard of care of monitoring temperature but will be administered Tylenol and body wraps if a fever develops.
Group II: Body wrapExperimental Treatment1 Intervention
This group will receive the body wraps post surgery to maintain normothermia.
Group III: TylenolActive Control1 Intervention
This group will receive the standard of care of monitoring temperature and administering Tylenol if a fever develops.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
697 Previous Clinical Trials
22,884,996 Total Patients Enrolled
Stryker MedicalIndustry Sponsor
3 Previous Clinical Trials
283 Total Patients Enrolled
Vishal Yajnik, MD, MSPrincipal InvestigatorVirginia Commonwealth University

Media Library

Active Temperature Management (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03947671 — Phase 2
Cardiac Surgery Research Study Groups: Tylenol, Tylenol with body wrap, Body wrap
Cardiac Surgery Clinical Trial 2023: Active Temperature Management Highlights & Side Effects. Trial Name: NCT03947671 — Phase 2
Active Temperature Management (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03947671 — Phase 2

Frequently Asked Questions

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

Is this clinical trial enlisting participants above the age of sixty?

"As per the criteria for enrolment, eligible participants must be between 20 and 89 years old. There are 82 clinical trials available to minors under 18 and 704 specifically designed for patients over 65."

Answered by AI

Are there any open spots currently available to join this investigation?

"According to the records on clinicaltrials.gov, this experiment is still open for participation and was first launched back in January 22nd of 2020. The latest update occurred on March 7th 2022."

Answered by AI

What is the current enrollment rate for this clinical trial?

"Affirmative. According to the clinicaltrials.gov database, this ongoing study was first published on January 22nd 2020 and last edited on March 7th 2022; it is currently searching for 172 participants from a single research centre."

Answered by AI

What medical issues can be remedied by Acetaminophen?

"Acetaminophen is a common medicine used to alleviate catarrh, rhinorrhoea, muscular pain and spasms."

Answered by AI

Is Acetaminophen a risk-free medication for patients?

"After evaluating the Acetaminophen Phase 2 trial, our team at Power concluded that it warrants a safety rating of 2. This is due to limited supporting evidence for its efficacy, but multiple studies confirming its safety."

Answered by AI

Do I meet the qualifications to join this scientific experiment?

"This medical trial seeks to include 172 individuals with fever and between 20-89 years of age."

Answered by AI

Could you please elucidate on any prior research conducted regarding Acetaminophen?

"At the moment, 89 clinical trials related to Acetaminophen are active, with 26 at Phase 3. While most of these studies initiated in Pittsburgh, Pennsylvania, there exist over 1000 locations for conducting experiments involving this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction
2020. "Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03947671.
~0 spots leftby Oct 2026
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