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 range20 Years – 89 Years

SexALL

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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
✕. patients with planned intraoperative circulatory arrest
✕. prisoners
✕. pregnant patients
✕. patients with symptomatic cerebrovascular disease, specifically residual motor deficits, expressive or receptive aphasia from prior stroke or cerebrovascular accident

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