Delirium - PostoperativeSPOT_ON_BRAINNCT07411612
The Association Between Postoperative Inflammatory and Neurological Serum Biomarker Concentrations and Occurrence of Postoperative Delirium
An observational study of Delirium - Postoperative and Neuronal Damage, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Postoperative delirium is a frequent and serious complication in older surgical patients, linked to prolonged hospitalization and long-term cognitive decline. The pathogenesis of delirium possibly includes inflammation and blood-brain barrier disruption. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium - Postoperative, Neuronal Damage, Blood Brain Barrier Defect
- What is being tested?
- laboratory biomarker analysis and 3D-CAM/CAM-ICU
- How many people
- 1,170 participants
- Where
- 1 siteAustria
- Study dates
- 12 Jan 2026to 18 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over the age of 65 years undergoing elective major non-cardiac, non-intrcranial, non-vascular surgery
Who may be able to join
- Provide written informed consent
- ≥ 65 years of age
- Scheduled for elective major non-cardiac, non-intrcranial, non-vascular surgery with estimated time of surgery ≥ 2 hours
Who cannot join
- Patients undergoing emergency surgery
- History of diagnosed dementia
- Language, vision, or hearing impairments that may compromise cognitive assessments
- Preoperative delirium
- ICU patients undergoing surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Therese Lingitz, Dr. med. univ. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Christian Reiterer, PD DDr., 004340400 ext. 20760, christian.reiterer@meduniwien.ac.at
About this study
Official title: The Association Between Postoperative Inflammatory and Neuroogical Serum Biomarker Concentrations and Occurrence of Postoperative Delirium - a Prospective Observational Study
Postoperative delirium is a frequent and serious complication in older surgical patients, linked to prolonged hospitalization and long-term cognitive decline. The pathogenesis of delirium possibly includes inflammation and blood-brain barrier disruption. Early identification of at-risk patients is limited by the lack of reliable biomarkers. Therefore, we will evaluate as our primary aim the association between S100B measured within 2 hours after surgery and the occurrence of postoperative delirium within the first three postoperative days in patients over the age of 65 undergoing major non-cardiac, non-intracranial and non-vascular surgery. We will further evaluate the association between NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will also evaluate the predictive value of S100B, NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will measure S100B, NSE, IL-6, and Copeptin preoperatively, within two hours after surgery and daily for the first three postoperative days. Delirium will be assessed twice daily in the morning and evening for the first three postoperative days.
In the course of this study we will establish a biobank of plasma and serum samples of patients, which are drawn preoperatively and within the first two hours after surgery.
- Conditions
- Delirium - Postoperative, Neuronal Damage, Blood Brain Barrier Defect, Postoperative Complications, Inflammation
- Being tested
- laboratory biomarker analysis, 3D-CAM/CAM-ICU
- Medical subject headings
- Emergence Delirium, Postoperative Complications, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisDiagnostic test
Neuronal, inflammatory and stress biomarkers will be obtained preoperatively, within 2 hours after surgery, on the first, second and third postoperative day
3D-CAM/CAM-ICUDiagnostic test
3D-CAM/CAM-ICU will be performed on the evening after surgery and in the morning and evening of the first three postoperative days
| Study group | Role | What they receive |
|---|---|---|
| Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery | Not described Receives: Diagnostic Test: laboratory biomarker analysis; Diagnostic Test: 3D-CAM/CAM-ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Secondary outcomes (7)
Association between postoperative NSE concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Association between postoperative IL-6 concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Association between postoperative Copeptin concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Predictive value of S100B concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Predictive value of NSE concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Predictive value of IL-6 concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Predictive value of Copeptin concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
Measured: within three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Jan 2026
- Primary completion15 Jan 2030 (estimated)
- Study completion18 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 1,170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Reiterer, Medical University of Vienna
- Investigators
- Christian Reiterer, PD DDr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411612
- Sponsor's protocol ID
- SPOT_ON_BRAIN_01
- Acronym
- SPOT_ON_BRAIN
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Postoperative Inflammatory and Neuroogical Serum Biomarker Concentrations and Occurrence of Postoperative Delirium - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07411612
- Acronym / sponsor ID
- SPOT_ON_BRAIN / SPOT_ON_BRAIN_01
- Conditions
- Delirium - Postoperative, Neuronal Damage, Blood Brain Barrier Defect, Postoperative Complications, Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,170 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 15 Jan 2030 (estimated)
- Study completion
- 18 Jan 2030 (estimated)
- First posted
- 17 Feb 2026 (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.
Postoperative delirium is a frequent and serious complication in older surgical patients, linked to prolonged hospitalization and long-term cognitive decline. The pathogenesis of delirium possibly includes inflammation and blood-brain barrier disruption. Early identification of at-risk patients is limited by the lack of reliable biomarkers. Therefore, we will evaluate as our primary aim the association between S100B measured within 2 hours after surgery and the occurrence of postoperative delirium within the first three postoperative days in patients over the age of 65 undergoing major non-cardiac, non-intracranial and non-vascular surgery. We will further evaluate the association between NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will also evaluate the predictive value of S100B, NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will measure S100B, NSE, IL-6, and Copeptin preoperatively, within two hours after surgery and daily for the first three postoperative days. Delirium will be assessed twice daily in the morning and evening for the first three postoperative days.
In the course of this study we will establish a biobank of plasma and serum samples of patients, which are drawn preoperatively and within the first two hours after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery | – | Diagnostic Test: laboratory biomarker analysis, Diagnostic Test: 3D-CAM/CAM-ICU |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over the age of 65 years undergoing elective major non-cardiac, non-intrcranial, non-vascular surgery
Key inclusion criteria (3 listed)
- Provide written informed consent
- ≥ 65 years of age
- Scheduled for elective major non-cardiac, non-intrcranial, non-vascular surgery with estimated time of surgery ≥ 2 hours
Key exclusion criteria (5 listed)
- Patients undergoing emergency surgery
- History of diagnosed dementia
- Language, vision, or hearing impairments that may compromise cognitive assessments
- Preoperative delirium
- ICU patients undergoing surgery
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 |
|---|---|---|
| laboratory biomarker analysisNeuronal, inflammatory and stress biomarkers will be obtained preoperatively, within 2 hours after surgery, on the first, second and third postoperative day | Diagnostic test | Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery |
| 3D-CAM/CAM-ICU3D-CAM/CAM-ICU will be performed on the evening after surgery and in the morning and evening of the first three postoperative days | Diagnostic test | Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery |
Primary outcome
Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium
Time frame: within three days after surgery
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
7 secondary outcomes
Association between postoperative NSE concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Time frame: within three days after surgery
Association between postoperative IL-6 concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Time frame: within three days after surgery
Association between postoperative Copeptin concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Time frame: within three days after surgery
Predictive value of S100B concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Time frame: within three days after surgery
Predictive value of NSE concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Time frame: within three days after surgery
Predictive value of IL-6 concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Time frame: within three days after surgery
Predictive value of Copeptin concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days
Time frame: within three days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- 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.
Marie-Therese Lingitz, Dr. med. univ. contact
Christian Reiterer, PD DDr. principal investigator
Medical University of Vienna
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 - Postoperative and Neuronal Damage, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Hantakova, Dr. med. univ. (004340400 ext. 20760, nicole.hantakova@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium (time frame: within three days after surgery). 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 17 Feb 2026.