RecruitingNCT07411612

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

The Association Between Postoperative Inflammatory and Neuroogical Serum Biomarker Concentrations and Occurrence of Postoperative Delirium - a Prospective Observational Study


Sponsor

Medical University of Vienna

Enrollment

1,170 participants

Start Date

Jan 12, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Inclusion Criteria3

  • 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

Exclusion Criteria5

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

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Interventions

DIAGNOSTIC_TESTlaboratory biomarker analysis

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

DIAGNOSTIC_TEST3D-CAM/CAM-ICU

3D-CAM/CAM-ICU will be performed on the evening after surgery and in the morning and evening of the first three postoperative days


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT07411612


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