The Association Between Postoperative Inflammatory and Neurological Serum Biomarker Concentrations and Occurrence of Postoperative Delirium

NCT07411612 | Recruiting

• 1 other identifier: SPOT_ON_BRAIN_01
• Study Type: observational
• Target: 1,170
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  within three days after surgery

Study Arms (1)

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

Interventions

laboratory biomarker analysis DIAGNOSTIC_TEST

Neuronal, inflammatory and stress biomarkers will be obtained preoperatively, within 2 hours after surgery, on the first, second and third postoperative day

Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery

3D-CAM/CAM-ICU DIAGNOSTIC_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

Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 65 years undergoing elective major non-cardiac, non-intrcranial, non-vascular surgery

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing emergency surgery
• History of diagnosed dementia
• Language, vision, or hearing impairments that may compromise cognitive assessments
• Preoperative delirium
• ICU patients undergoing surgery

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum + Plasma (Biobank)

MeSH Terms

Conditions

Emergence Delirium; Postoperative Complications; Inflammation

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christian Reiterer, PD DDr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Hantakova, Dr. med. univ.

CONTACT

004340400; nicole.hantakova@meduniwien.ac.at

Marie-Therese Lingitz, Dr. med. univ.

CONTACT

004340400; marie-therese.lingitz@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 17, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 15, 2030
• Study Completion (Estimated): January 18, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)