DeliriumNCT03110185
Postoperative Delirium: Brain Vulnerability and Recovery
A study testing EEG, fcDOT and fcMRI in people with Delirium and Postoperative Complications, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Postoperative Complications
- What is being tested?
- EEG, fcDOT and fcMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2015to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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:
- Not delirious as diagnosed by the CAM/CAM-ICU on postoperative day 1-5.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Delirium, Postoperative Complications
- Being tested
- EEG, fcDOT, fcMRI
- Medical subject headings
- Delirium, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
Also called brain monitoring in delirious postoperative patients
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcDOTDevice
Also called brain monitoring in delirious postoperative patients
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcMRIDevice
Also called brain monitoring in delirious postoperative patients
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
| Study group | Role | What they receive |
|---|---|---|
| delirium | Other | 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. Receives: Device: EEG; Device: fcDOT; Device: fcMRI |
| no delirium | Other | Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm Receives: Device: EEG; Device: fcDOT; Device: fcMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data acquisition will occur on 4 separate days between postoperative days 1-8.
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.
Measured: Data acquisition will occur on 4 separate days between postoperative days 1-8.
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
Measured: Within one month after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start25 Nov 2015
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Palanca, Washington University School of Medicine
- Investigators
- Ben Palanca, MD, PhD, MSc, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110185
- Sponsor's protocol ID
- 201511004
- Status last verified
- May 2020
- First submitted
- 14 Jan 2016
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium: Brain Vulnerability and Recovery
- ClinicalTrials.gov ID
- NCT03110185
- Acronym / sponsor ID
- 201511004
- Conditions
- Delirium, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirium | Other | Device: EEG, Device: fcDOT, Device: fcMRIPatients 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. |
| no delirium | Other | Device: EEG, Device: fcDOT, Device: fcMRIPatients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGAlso: brain monitoring in delirious postoperative patientsBrain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. | Device | delirium, no delirium |
| fcDOTAlso: brain monitoring in delirious postoperative patientsBrain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. | Device | delirium, no delirium |
| fcMRIAlso: brain monitoring in delirious postoperative patientsBrain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. | Device | delirium, no delirium |
Primary outcome
EEG During Delirium and After Recovery and in Patient Controls.
Time frame: Data acquisition will occur on 4 separate days between postoperative days 1-8.
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
Time frame: Data acquisition will occur on 4 separate days between postoperative days 1-8.
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.
Time frame: Within one month after hospital discharge.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Palanca, MD, PhD, MSc principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG, fcDOT and fcMRI in people with Delirium and Postoperative Complications, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG During Delirium and After Recovery and in Patient Controls. (time frame: Data acquisition will occur on 4 separate days between postoperative days 1-8.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.