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Postoperative Delirium: Brain Vulnerability and Recovery

Primary Purpose

Delirium, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EEG
fcDOT
fcMRI
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Common inclusion criteria:

  1. Age ≥ 60
  2. Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement
  3. English speaking.

Common exclusion criteria:

  1. Implanted pacemaker
  2. Automatic internal cardiac defibrillator or other implant for which non-contrast magnetic resonance imaging (MRI) is contraindicated
  3. Concomitant aortic or cerebrovascular procedure
  4. Inability to lay flat or still for MRI
  5. Legal blindness or severe deafness
  6. Seizure history
  7. Known focal brain lesion larger than 3 cm.

Delirium Case Arm:

1. Delirious as diagnosed by the Confusion Assessment Method (CAM)/ Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at some point during postoperative day 1-5.

Postoperative Control Arm:

1. Not delirious as diagnosed by the CAM/CAM-ICU on postoperative day 1-5.

Sites / Locations

  • Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

delirium

no delirium

Arm Description

Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.

Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm

Outcomes

Primary Outcome Measures

EEG During Delirium and After Recovery and in Patient Controls.
Delta (0.5-4 Hz), theta (4-8 Hz), and alpha (8-12 Hz) EEG waveforms.
Functional Connectivity Diffuse Optical Tomography (fcDOT) in Patients During Delirium and After Recovery and in Patient Controls
Functional connectivity between anterior and posterior Default Mode Network regions using diffuse optical imaging.
Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls.
Functional connectivity between anterior and posterior Default Mode Network regions assessed from resting-state fcMRI acquired during eyes open wakefulness. Scored using r-value, using a scale of -1 to +1. -1 = strong negative correlation, +1 = strong positive correlation

Secondary Outcome Measures

Full Information

First Posted
January 14, 2016
Last Updated
May 23, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03110185
Brief Title
Postoperative Delirium: Brain Vulnerability and Recovery
Official Title
Postoperative Delirium: Brain Vulnerability and Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 25, 2015 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, we propose to use EEG and a brain imaging technique known as diffuse optical tomography (DOT) to study when people are in delirium and when they recovery. We plan to also compare brain function of patients who recovered from delirium to patients who did not have delirium using DOT and fMRI. We will also continually monitor the participant's EMR to help coordinate timing of study procedures, as well as to collect information pertaining to their surgery, recovery progress, and indicators of mental status including delirium.
Detailed Description
Postoperative delirium - a mental state of confusion, inattention, and impaired thought - is a potentially life-threatening condition. As many as half of patients that have heart and non heart-related surgery will experience postoperative delirium. Patients diagnosed with postoperative delirium have poorer outcomes and longer hospitalizations. Unfortunately, it is an under-diagnosed condition with a variable delay in when it appears. Additionally, there are no objective tools or tests that can be before or after surgery to anticipate and identify those patients who are at risk. Electroencephalography [EEG] and functional magnetic resonance imaging [fMRI] have helped us understand the changes in the brain during delirium. These suggest that a weakening in correlated activity within a group of brain regions, known as the default mode network (DMN), may be related to delirium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Postoperative Complications

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
delirium
Arm Type
Other
Arm Description
Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.
Arm Title
no delirium
Arm Type
Other
Arm Description
Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm
Intervention Type
Device
Intervention Name(s)
EEG
Other Intervention Name(s)
brain monitoring in delirious postoperative patients
Intervention Description
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
Intervention Type
Device
Intervention Name(s)
fcDOT
Other Intervention Name(s)
brain monitoring in delirious postoperative patients
Intervention Description
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
Intervention Type
Device
Intervention Name(s)
fcMRI
Other Intervention Name(s)
brain monitoring in delirious postoperative patients
Intervention Description
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
Primary Outcome Measure Information:
Title
EEG During Delirium and After Recovery and in Patient Controls.
Description
Delta (0.5-4 Hz), theta (4-8 Hz), and alpha (8-12 Hz) EEG waveforms.
Time Frame
Data acquisition will occur on 4 separate days between postoperative days 1-8.
Title
Functional Connectivity Diffuse Optical Tomography (fcDOT) in Patients During Delirium and After Recovery and in Patient Controls
Description
Functional connectivity between anterior and posterior Default Mode Network regions using diffuse optical imaging.
Time Frame
Data acquisition will occur on 4 separate days between postoperative days 1-8.
Title
Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls.
Description
Functional connectivity between anterior and posterior Default Mode Network regions assessed from resting-state fcMRI acquired during eyes open wakefulness. Scored using r-value, using a scale of -1 to +1. -1 = strong negative correlation, +1 = strong positive correlation
Time Frame
Within one month after hospital discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Common inclusion criteria: Age ≥ 60 Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement English speaking. Common exclusion criteria: Implanted pacemaker Automatic internal cardiac defibrillator or other implant for which non-contrast magnetic resonance imaging (MRI) is contraindicated Concomitant aortic or cerebrovascular procedure Inability to lay flat or still for MRI Legal blindness or severe deafness Seizure history Known focal brain lesion larger than 3 cm. Delirium Case Arm: 1. Delirious as diagnosed by the Confusion Assessment Method (CAM)/ Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at some point during postoperative day 1-5. Postoperative Control Arm: 1. Not delirious as diagnosed by the CAM/CAM-ICU on postoperative day 1-5.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Palanca, MD, PhD, MSc
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Delirium: Brain Vulnerability and Recovery

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