DeliriumINTUITNCT03273335
Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults
An observational study of Delirium, run by Duke University at 1 site in United States.
Trial summary
(From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Read more about this study
- Who is it for?
- Ages 60 to 130 years
- Conditions the study is for
- Delirium
- What is being tested?
- Millipore biomarker assay plate
- Type of treatment
- Medical device
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 21 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients age 60 and above, as described above.
Who may be able to join
- Age 60 and above
- Having surgery scheduled to last > or = to 2 hours at Duke University Medical Center (ie Duke Hospital, Duke Medicine Pavilion, Duke Regional Hospital, Durham VA, Duke Raleigh Hospital)
Who cannot join
- Anticoagulants (per ASRA guidelines)
- Current use of chemotherapeutic agents with known cognitive effects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27712
About this study
(From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.
Read the detailed description
Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.
- Conditions
- Delirium
- Being tested
- Millipore biomarker assay plate
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Millipore biomarker assay plateDevice
Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Surgical patients will undergo CSF biomarker assays, cognitive testing and fMRI scans. Receives: Device: Millipore biomarker assay plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Perioperative changes in CSF Monocytes and perioperative changes in cognition (continuous cognitive index change)
as above
Measured: from before to 6 weeks after anesthesia/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start15 Jun 2017
- Primary completion11 Nov 2021
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Miles Berger, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273335
- Sponsor's protocol ID
- Pro00083288
- Other IDs
- 1K76AG057022
- Acronym
- INTUIT
- Status last verified
- Nov 2022
- First submitted
- 3 Sep 2017
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Devinney MJ, Takla J, VanDusen K, Wright MC, Spector AR, Thomas J, Avasarala P, Hall A, Syed A, Adams M, Moretti E, Dominguez JE, Smith PJ, Wong MK, Cai V, Eleswarpu S, Browndyke JN, Cohen HJ, Whitson HE, Veasey SC, Treggiari M, Blennow K, Zetterberg H, Mathew JP, Berger M; INTUIT Study Investigators. Preoperative Moderate-Severe Excessive Daytime Sleepiness Is Associated With Postoperative Cognitive Dysfunction in Older Surgical Patients. J Am Geriatr Soc. 2026 Aug 30. doi: 10.1111/jgs.70685. Online ahead of print.
PubMed 42668427Devinney MJ, Spector AR, Wright MC, Thomas J, Avasarala P, Moretti E, Dominguez JE, Smith PJ, Whitson HE, Veasey SC, Mathew JP, Berger M; the INTUIT Study Investigators. The Role of Sleep Apnea in Postoperative Neurocognitive Disorders Among Older Noncardiac Surgery Patients: A Prospective Cohort Study. Anesth Analg. 2025 Jan 1;140(1):99-109. doi: 10.1213/ANE.0000000000007269. Epub 2024 Nov 22.
PubMed 39688967Berger M, Murdoch DM, Staats JS, Chan C, Thomas JP, Garrigues GE, Browndyke JN, Cooter M, Quinones QJ, Mathew JP, Weinhold KJ; MADCO-PC Study Team. Flow Cytometry Characterization of Cerebrospinal Fluid Monocytes in Patients With Postoperative Cognitive Dysfunction: A Pilot Study. Anesth Analg. 2019 Nov;129(5):e150-e154. doi: 10.1213/ANE.0000000000004179.
PubMed 31085945
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults
- ClinicalTrials.gov ID
- NCT03273335
- Acronym / sponsor ID
- INTUIT / Pro00083288
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.
Detailed description
Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | Device: Millipore biomarker assay plateSurgical patients will undergo CSF biomarker assays, cognitive testing and fMRI scans. |
Who may qualify
- Ages
- 60 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients age 60 and above, as described above.
Key inclusion criteria (2 listed)
- Age 60 and above
- Having surgery scheduled to last > or = to 2 hours at Duke University Medical Center (ie Duke Hospital, Duke Medicine Pavilion, Duke Regional Hospital, Durham VA, Duke Raleigh Hospital)
Key exclusion criteria (2 listed)
- Anticoagulants (per ASRA guidelines)
- Current use of chemotherapeutic agents with known cognitive effects.
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 |
|---|---|---|
| Millipore biomarker assay plateMillipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry | Device | Surgical patients |
Primary outcome
Correlation between Perioperative changes in CSF Monocytes and perioperative changes in cognition (continuous cognitive index change)
Time frame: from before to 6 weeks after anesthesia/surgery
as above
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 42668427Devinney MJ, Takla J, VanDusen K, Wright MC, Spector AR, Thomas J, Avasarala P, Hall A, Syed A, Adams M, Moretti E, Dominguez JE, Smith PJ, Wong MK, Cai V, Eleswarpu S, Browndyke JN, Cohen HJ, Whitson HE, Veasey SC, Treggiari M, Blennow K, Zetterberg H, Mathew JP, Berger M; INTUIT Study Investigators. Preoperative Moderate-Severe Excessive Daytime Sleepiness Is Associated With Postoperative Cognitive Dysfunction in Older Surgical Patients. J Am Geriatr Soc. 2026 Aug 30. doi: 10.1111/jgs.70685. Online ahead of print.
- Derived from this study: PubMed 39688967Devinney MJ, Spector AR, Wright MC, Thomas J, Avasarala P, Moretti E, Dominguez JE, Smith PJ, Whitson HE, Veasey SC, Mathew JP, Berger M; the INTUIT Study Investigators. The Role of Sleep Apnea in Postoperative Neurocognitive Disorders Among Older Noncardiac Surgery Patients: A Prospective Cohort Study. Anesth Analg. 2025 Jan 1;140(1):99-109. doi: 10.1213/ANE.0000000000007269. Epub 2024 Nov 22.
- Derived from this study: PubMed 31085945Berger M, Murdoch DM, Staats JS, Chan C, Thomas JP, Garrigues GE, Browndyke JN, Cooter M, Quinones QJ, Mathew JP, Weinhold KJ; MADCO-PC Study Team. Flow Cytometry Characterization of Cerebrospinal Fluid Monocytes in Patients With Postoperative Cognitive Dysfunction: A Pilot Study. Anesth Analg. 2019 Nov;129(5):e150-e154. doi: 10.1213/ANE.0000000000004179.
- Individual participant dataSharing planned: Undecided
Related trials for Delirium
Active, not recruiting
TaVNS for Delirium
Delirium
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
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.
Miles Berger, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Duke University 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?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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 16 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between Perioperative changes in CSF Monocytes and perioperative changes in cognition (continuous cognitive index change) (time frame: from before to 6 weeks after anesthesia/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273335, which also lists 3 linked publications.
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 16 Nov 2022.