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NCT Number: NCT07411612

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

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.

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Key information

Conditions

Delirium - Postoperative Blood Brain Barrier Defect Confusion Delirium Emergence Delirium Inflammation Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neuronal Damage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Christian Reiterer, PD DDr.

CONTACT

[email protected]

004340400 ext. 20760

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium

    Time frame: within three days after surgery

    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.

Secondary outcomes

  1. 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

    Time frame: within three days after surgery

    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.

  2. 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

    Time frame: within three days after surgery

    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.

  3. 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

    Time frame: within three days after surgery

    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.

  4. 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

    Time frame: within three days after surgery

    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.

  5. 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

    Time frame: within three days after surgery

    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.

  6. Predictive value of IL-6 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

    Time frame: within three days after surgery

    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.

  7. Predictive value of Copeptin 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

    Time frame: within three days after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Therese Lingitz, Dr. med. univ.

CONTACT

[email protected]

004340400 ext. 20760

Nicole Hantakova, Dr. med. univ.

CONTACT

[email protected]

004340400 ext. 20760

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: SPOT_ON_BRAIN

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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