DeliriumIPOD-B2NCT02926417
Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2)
An observational study of Delirium, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients undergoing major surgery. The investigators will identify then correlate soluble biomarkers in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- High Density-Electroencephalogram
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 26 Nov 2019
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing elective open thoracoabdominal aortic aneurysm or thoracic endovascular aortic/aneurysm repair surgery.
Who may be able to join
- Adult (>21 years old)
- Patients scheduled for an elective open thoracoabdominal aortic aneurysm or TEVAR (thoracic endovascular aortic/aneurysm repair)
- Requiring spinal drain for surgery that is predicted to stay in two or more days
- Willing and able to provide informed consent
Who cannot join
- Contraindication for spinal drain
- Documented history of dementia
- Unable to communicate with the research staff due to language barriers
- Individuals who the PI determines are not appropriate for the study such as a history of appointment cancellations.
- Pregnant or Nursing
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
Official title: Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2) Pilot Study
The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients undergoing major surgery. The investigators will identify then correlate soluble biomarkers in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.
- Conditions
- Delirium
- Being tested
- High Density-Electroencephalogram
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Density-ElectroencephalogramProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes
Measured: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Secondary outcomes (4)
Absolute changes in biomarkers in CSF and plasma in delirious and non-delirious patients between baseline and post-operative period
Measured: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients
Measured: Post-operative measure: Up to postoperative day (POD) 9
Absolute changes in activity and connectivity in HD-EEG from baseline to postoperative
Measured: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Correlation of biomarkers with the incidence of spinal cord ischemia
Measured: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJun 2016
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Lennertz, MD PhD, Principal investigator, University of Wisconsin-Madison, School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926417
- Sponsor's protocol ID
- 2015-0960
- Other IDs
- A530900, SMPH/ANESTHESIOLOGY/ANESTHESIO, Protocol Version 4/20/2020
- Acronym
- IPOD-B2
- Status last verified
- Oct 2021
- First submitted
- 16 Sep 2016
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu JG, Taylor J, Kunkel D, Maze M, Pearce RA, Sanders RD, Lennertz R. The association between cerebrospinal fluid interleukin-6, soluble interleukin-6 receptor, and interleukin-6 trans-signalling binary complex with postoperative delirium: an observational cohort study. BJA Open. 2026 Apr 10;18:100546. doi: 10.1016/j.bjao.2026.100546. eCollection 2026 Jun.
PubMed 42011187Taylor J, Parker M, Casey CP, Tanabe S, Kunkel D, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, Sanders RD. Postoperative delirium and changes in the blood-brain barrier, neuroinflammation, and cerebrospinal fluid lactate: a prospective cohort study. Br J Anaesth. 2022 Aug;129(2):219-230. doi: 10.1016/j.bja.2022.01.005. Epub 2022 Feb 8.
PubMed 35144802Tanabe S, Parker M, Lennertz R, Pearce RA, Banks MI, Sanders RD. Reduced Electroencephalogram Complexity in Postoperative Delirium. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):502-506. doi: 10.1093/gerona/glab352.
PubMed 34958346Parker M, White M, Casey C, Kunkel D, Bo A, Blennow K, Zetterberg H, Pearce RA, Lennertz R, Sanders RD. Cohort Analysis of the Association of Delirium Severity With Cerebrospinal Fluid Amyloid-Tau-Neurodegeneration Pathologies. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):494-501. doi: 10.1093/gerona/glab203.
PubMed 34260706Ballweg T, White M, Parker M, Casey C, Bo A, Farahbakhsh Z, Kayser A, Blair A, Lindroth H, Pearce RA, Blennow K, Zetterberg H, Lennertz R, Sanders RD. Association between plasma tau and postoperative delirium incidence and severity: a prospective observational study. Br J Anaesth. 2021 Feb;126(2):458-466. doi: 10.1016/j.bja.2020.08.061. Epub 2020 Nov 20.
PubMed 33228978Tanabe S, Mohanty R, Lindroth H, Casey C, Ballweg T, Farahbakhsh Z, Krause B, Prabhakaran V, Banks MI, Sanders RD. Cohort study into the neural correlates of postoperative delirium: the role of connectivity and slow-wave activity. Br J Anaesth. 2020 Jul;125(1):55-66. doi: 10.1016/j.bja.2020.02.027. Epub 2020 Jun 1.
PubMed 32499013
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2) Pilot Study
- ClinicalTrials.gov ID
- NCT02926417
- Acronym / sponsor ID
- IPOD-B2 / 2015-0960
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients undergoing major surgery. The investigators will identify then correlate soluble biomarkers in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective open thoracoabdominal aortic aneurysm or thoracic endovascular aortic/aneurysm repair surgery.
Key inclusion criteria (4 listed)
- Adult (>21 years old)
- Patients scheduled for an elective open thoracoabdominal aortic aneurysm or TEVAR (thoracic endovascular aortic/aneurysm repair)
- Requiring spinal drain for surgery that is predicted to stay in two or more days
- Willing and able to provide informed consent
Key exclusion criteria (6 listed)
- Contraindication for spinal drain
- Documented history of dementia
- Unable to communicate with the research staff due to language barriers
- Individuals who the PI determines are not appropriate for the study such as a history of appointment cancellations.
- Pregnant or Nursing
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 |
|---|---|---|
| High Density-Electroencephalogram | Procedure or surgery | – |
Primary outcome
Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
4 secondary outcomes
Absolute changes in biomarkers in CSF and plasma in delirious and non-delirious patients between baseline and post-operative period
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients
Time frame: Post-operative measure: Up to postoperative day (POD) 9
Absolute changes in activity and connectivity in HD-EEG from baseline to postoperative
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Correlation of biomarkers with the incidence of spinal cord ischemia
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
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 1 Nov 2021.
- Derived from this study: PubMed 42011187Wu JG, Taylor J, Kunkel D, Maze M, Pearce RA, Sanders RD, Lennertz R. The association between cerebrospinal fluid interleukin-6, soluble interleukin-6 receptor, and interleukin-6 trans-signalling binary complex with postoperative delirium: an observational cohort study. BJA Open. 2026 Apr 10;18:100546. doi: 10.1016/j.bjao.2026.100546. eCollection 2026 Jun.
- Derived from this study: PubMed 35144802Taylor J, Parker M, Casey CP, Tanabe S, Kunkel D, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, Sanders RD. Postoperative delirium and changes in the blood-brain barrier, neuroinflammation, and cerebrospinal fluid lactate: a prospective cohort study. Br J Anaesth. 2022 Aug;129(2):219-230. doi: 10.1016/j.bja.2022.01.005. Epub 2022 Feb 8.
- Derived from this study: PubMed 34958346Tanabe S, Parker M, Lennertz R, Pearce RA, Banks MI, Sanders RD. Reduced Electroencephalogram Complexity in Postoperative Delirium. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):502-506. doi: 10.1093/gerona/glab352.
- Derived from this study: PubMed 34260706Parker M, White M, Casey C, Kunkel D, Bo A, Blennow K, Zetterberg H, Pearce RA, Lennertz R, Sanders RD. Cohort Analysis of the Association of Delirium Severity With Cerebrospinal Fluid Amyloid-Tau-Neurodegeneration Pathologies. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):494-501. doi: 10.1093/gerona/glab203.
- Derived from this study: PubMed 33228978Ballweg T, White M, Parker M, Casey C, Bo A, Farahbakhsh Z, Kayser A, Blair A, Lindroth H, Pearce RA, Blennow K, Zetterberg H, Lennertz R, Sanders RD. Association between plasma tau and postoperative delirium incidence and severity: a prospective observational study. Br J Anaesth. 2021 Feb;126(2):458-466. doi: 10.1016/j.bja.2020.08.061. Epub 2020 Nov 20.
- Derived from this study: PubMed 32499013Tanabe S, Mohanty R, Lindroth H, Casey C, Ballweg T, Farahbakhsh Z, Krause B, Prabhakaran V, Banks MI, Sanders RD. Cohort study into the neural correlates of postoperative delirium: the role of connectivity and slow-wave activity. Br J Anaesth. 2020 Jul;125(1):55-66. doi: 10.1016/j.bja.2020.02.027. Epub 2020 Jun 1.
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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.
Richard Lennertz, MD PhD principal investigator
University of Wisconsin-Madison, School of Medicine and Public Health
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 University of Wisconsin, Madison 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 4 inclusion and 6 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 1 Nov 2021. 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?
Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes (time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9). 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 NCT02926417, which also lists 6 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 1 Nov 2021.