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

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ClinicalTrials.gov Identifier: NCT03947671
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Stryker Medical
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Post-operative Cognitive Dysfunction Fever Device: Rapr Rounds Hyper/Hypothermia Wraps Drug: Acetaminophen Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Body wrap
This group will receive the body wraps post surgery to maintain normothermia.
Device: Rapr Rounds Hyper/Hypothermia Wraps
Rapr Round® vest and leg wraps will placed around the torso and legs of the participant and will be adjusted to maintain normal body temperature

Active Comparator: Tylenol
This group will receive the standard of care of monitoring temperature and administering Tylenol if a fever develops.
Drug: Acetaminophen
Acetaminophen will be administered as it would be per standard of care
Other Name: Tylenol

Experimental: Tylenol with body wrap
This group will receive the standard of care of monitoring temperature but will be administered Tylenol and body wraps if a fever develops.
Device: Rapr Rounds Hyper/Hypothermia Wraps
Rapr Round® vest and leg wraps will placed around the torso and legs of the participant and will be adjusted to maintain normal body temperature

Drug: Acetaminophen
Acetaminophen will be administered as it would be per standard of care
Other Name: Tylenol




Primary Outcome Measures :
  1. Change in cognitive Function post CABG [ Time Frame: From pre surgery and 6 weeks post surgery ]

    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) administered by a clinical psychologist or re-searcher specifically trained by the clinical psychologist. The RBANS is a screening tool that has been standardized to measure the neu-ropsychological status of adult patient between the ages of 20 and 89. It is composed of 12 sub-tests and takes approximately 30 minutes to administer. It is scored using a scaled index score from 40 to 160 with the following score ranges:

    130 and above: very superior 120-129: superior 110-119: high average 90-109: average 80-89: low average 70-79: borderline 69 and below: extremely low



Secondary Outcome Measures :
  1. Variability in Temperature [ Time Frame: Up to 24 hours post surgery ]
    Pattern of body temperature during post-op period measured using electronic thermometers



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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. age < 20 years or > 89 years
  2. patients with unscheduled CABG +/- valve surgery (i.e. emergency surgery)
  3. deformity or skin condition of chest or thighs that would interfere with the successful placement of Rapr Round® vest and leg wraps
  4. patients presenting to the ICU postoperatively with a fever ≥ 38.3
  5. patients with planned intraoperative circulatory arrest
  6. prisoners
  7. pregnant patients
  8. patients with symptomatic cerebrovascular disease, specifically residual motor deficits, expressive or receptive aphasia from prior stroke or cerebrovascular accident

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947671


Contacts
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Contact: Anna Priday, MS 804-628-9612 anna.priday@vcuhealth.org
Contact: Kyle Narron kyle.narron@vcuhealth.org

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Anna Priday, MS    804-628-9612    anna.priday@vcuhealth.org   
Contact: Kyle Narron       kyle.narron@vcuhealth.org   
Sponsors and Collaborators
Virginia Commonwealth University
Stryker Medical
Investigators
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Principal Investigator: Vishal Yajnik, MD, MS Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03947671     History of Changes
Other Study ID Numbers: HM20015426
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Virginia Commonwealth University:
temperature regulation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics