Early post-op blood biomarkers and the risk of delirium after major surgery
The Association Between Postoperative Inflammatory and Neuroogical Serum Biomarker Concentrations and Occurrence of Postoperative Delirium - a Prospective Observational Study
We will test whether blood levels of S100B, NSE, IL-6, and Copeptin measured within two hours after surgery can help predict delirium in people 65 and older having major non-cardiac, non-intracranial, non-vascular elective surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1170 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT07411612 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort study enrolling patients aged 65 and older undergoing elective major non-cardiac, non-intracranial, non-vascular surgery lasting at least two hours. Blood samples taken within two hours after surgery will be analyzed for S100B, NSE, IL-6, and Copeptin concentrations. Participants will be monitored for postoperative delirium during the first three postoperative days using validated tools (3D-CAM or CAM-ICU). The primary aim is to test the association between early postoperative S100B levels and delirium occurrence, with secondary analyses for NSE, IL-6, and Copeptin and their predictive value. Patients with dementia, preoperative delirium, emergency procedures, or sensory/language barriers are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older who can give consent and are scheduled for elective major non-cardiac, non-intracranial, non-vascular surgery expected to last two hours or more, without a history of dementia or preoperative delirium.
Not a fit: Patients undergoing emergency surgery, those with diagnosed dementia or preoperative delirium, ICU surgery patients, or those with language/vision/hearing limitations preventing cognitive assessment are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, a simple early blood test could identify patients at high risk for postoperative delirium so clinicians can increase monitoring and apply preventive measures.
How similar studies have performed: Previous studies have reported associations between some of these biomarkers and delirium but results have been mixed and predictive accuracy remains uncertain.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Christian Reiterer, PD DDr. — Medical University of Vienna
- Study coordinator: Nicole Hantakova, Dr. med. univ.
- Email: nicole.hantakova@meduniwien.ac.at
- Phone: 004340400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.