NCT07411612

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,170 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	laboratory 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_TEST	3D-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

Timeline

• Start date: 2026-01-12
• Primary completion: 2030-01-15
• Completion: 2030-01-18
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Austria