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Recruiting NCT07411612

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

— Observational Delirium - Postoperative Neuronal Damage Blood Brain Barrier Defect Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: laboratory biomarker analysis, 3D-CAM/CAM-ICU.
Who it may be relevant to
Registry conditions: Delirium - Postoperative, Neuronal Damage, Blood Brain Barrier Defect, Postoperative Complications. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium [Time frame: within three days after surgery]
Secondary outcome measures (7)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Identifiers

NCT: NCT07411612 · SPOT_ON_BRAIN_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗