Postoperative Delirium: Brain Vulnerability and Recovery

Delirium Clinical Trial

Official title:

Postoperative Delirium: Brain Vulnerability and Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110185
• Other study ID #: 201511004
• Status: Completed
• Phase: N/A
• Start date: November 25, 2015
• Est. completion date: March 8, 2019

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Complications

Intervention

Device:
• EEG
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
• fcDOT
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
• fcMRI
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data acquisition will occur on 4 separate days between postoperative days 1-8.
Primary	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.	Data acquisition will occur on 4 separate days between postoperative days 1-8.
Primary	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	Within one month after hospital discharge.