About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients undergoing emergency surgery
History of diagnosed dementia
Language, vision, or hearing impairments that may compromise cognitive assessments
Preoperative delirium
Trial population
Patients over the age of 65 years undergoing elective major non-cardiac, non-intrcranial, non-vascular surgery
Trial design
Cohort
Prospective
Treatments tested in this trial
laboratory biomarker analysis
Diagnostic testNeuronal, 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 test3D-CAM/CAM-ICU will be performed on the evening after surgery and in the morning and evening of the first three postoperative days
Treatment groups
Trial outcomes
Primary outcomes
Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium
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
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
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.
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
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.
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
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.
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
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.
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