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

NCT03947671 | Withdrawn Phase 2 FDA Device

• 1 other identifier: HM20015426
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Post-operative Cognitive Dysfunction; Fever

Keywords

temperature regulation

Outcome Measures

Primary Outcomes (1)

• Change in cognitive Function post CABG

  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

  From pre surgery and 6 weeks post surgery

Secondary Outcomes (1)

• Variability in Temperature

  Up to 24 hours post surgery

Study Arms (3)

Body wrap

EXPERIMENTAL

This group will receive the body wraps post surgery to maintain normothermia.

Device: Rapr Rounds Hyper/Hypothermia Wraps

Tylenol

ACTIVE COMPARATOR

This group will receive the standard of care of monitoring temperature and administering Tylenol if a fever develops.

Drug: Acetaminophen

Tylenol with body wrap

EXPERIMENTAL

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; Drug: Acetaminophen

Interventions

Rapr Rounds Hyper/Hypothermia Wraps DEVICE

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

Body wrap; Tylenol with body wrap

Acetaminophen DRUG

Acetaminophen will be administered as it would be per standard of care

Also known as: Tylenol

Tylenol; Tylenol with body wrap

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Stryker Medical: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Vishal Yajnik, MD, MS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 13, 2019
• Study Start: January 22, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)