WithdrawnPhase 2

Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction

Stopped: Loss of funds

United States0Started 2020-01-22

Plain-language summary

This study will assess the effect of active postoperative temperature management and its effect on the cognitive function in patients following coronary artery bypass graft (CABG) surgery to determine if active postoperative temperature management to maintain normothermia reduces postoperative cognitive dysfunction (POCD) in this population. Additionally, the investigators will explore differences in temperature control variability by using temperature management wraps combined with acetaminophen vs. acetaminophen alone in a pilot arm.

Who can participate

Age range

20 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. scheduled coronary artery bypass graft surgery patients, with or without valve surgery
. patients able to give informed consent

Exclusion criteria

. age \< 20 years or \> 89 years
. patients with unscheduled CABG +/- valve surgery (i.e. emergency surgery)
. deformity or skin condition of chest or thighs that would interfere with the successful placement of Rapr Round® vest and leg wraps
. patients presenting to the ICU postoperatively with a fever ≥ 38.3

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in cognitive Function post CABG

Timeframe: From pre surgery and 6 weeks post surgery

Trial details

NCT IDNCT03947671

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Cardiac Surgery trials