NCT07411612 The Association Between Postoperative Inflammatory and Neurological Serum Biomarker Concentrations and Occurrence of Postoperative Delirium
| NCT ID | NCT07411612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Delirium - Postoperative |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,170 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2030-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,170 participants in total. It began in 2026-01-12 with a primary completion date of 2030-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Patients undergoing emergency surgery * History of diagnosed dementia * Language, vision, or hearing impairments that may compromise cognitive assessments * Preoperative delirium * ICU patients undergoing surgery
Contact & Investigator
Christian Reiterer, PD DDr.
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT07411612 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Delirium - Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07411612 currently recruiting?
Yes, NCT07411612 is actively recruiting participants. Contact the research team at nicole.hantakova@meduniwien.ac.at for enrollment information.
Where is the NCT07411612 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07411612 clinical trial?
NCT07411612 is sponsored by Medical University of Vienna. The principal investigator is Christian Reiterer, PD DDr. at Medical University of Vienna. The trial plans to enroll 1,170 participants.