Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD) (POCD)
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|ClinicalTrials.gov Identifier: NCT04837391|
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment|
|Postoperative Cognitive Dysfunction Postoperative Delirium Frailty||Device: Near Infrared Spectroscopy (NIRS) Diagnostic Test: Blood sample Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III) Diagnostic Test: Confusion Assessment Method|
The incidence of POCD changes by age group, type of surgery, testing neuropsychological tests, timing of tests, and the method used for diagnosis. In non-cardiac surgery over the age of 60; the incidence of POCD was 26% in the postoperative 1st week and 10% in the postoperative 3rd month. Although old age is an important risk factor, POCD incidence of up to 36.6% has been reported in a younger period. Major cancer surgery is an important risk factor for development of POCD.
Numerous biomarkers such as; S100β, NSE, Human IL-6, HMGB-1 protein; have been evaluated in studies to determine the diagnosis, prognosis, stage and treatment of POCD.
In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers. (S100β, NSE, Human IL-6 and HMGB-1 protein).The hypothesis of our study is that postoperative brain injury and inflammatory markers (S100β, NSE, Human IL-6 and HMGB-1 protein) will be higher in patients who develop POCD compared to patients who do not develop POCD in geriatric urologic oncology surgery.
|Study Type :||Observational|
|Estimated Enrollment :||48 participants|
|Official Title:||Evaluation of the Relationship Between Postoperative Cognitive Dysfunction and Brain Injury Biomarkers In Geriatric Urologic Oncology Patients|
|Actual Study Start Date :||April 21, 2020|
|Estimated Primary Completion Date :||May 21, 2021|
|Estimated Study Completion Date :||July 21, 2021|
Urologic oncology surgery in elderly
Elective urologic oncology surgeries such as radical nephrectomy, radical cystectomy, radical prostatectomy in older than 65 years
Device: Near Infrared Spectroscopy (NIRS)
Patients are monitored by near infrared spectroscopy before anesthesia induction until end of the operation. Graphical presentation of cerebral oxygenation during surgery evaluated by INVOS Analytics Tool Version 1.2.
Other Name: INVOS Cerebral Oximeter 5100C (Covidien Dublin, Ireland)
Diagnostic Test: Blood sample
Blood samples are obtained before and after surgery. S-100, Neuron specific enolase (NSE), Interleukin-6 (IL-6), High Mobility Group Box Protein (HMGB-1) are going to be studied by ELISA method after data collection process end.
Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III)
ACE-III is administered to study participants one day before surgery, 1 week after surgery, and three months after surgery to diagnose postoperative cognitive dysfunction.
Diagnostic Test: Confusion Assessment Method
Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.
- Addenbrooke cognitive examination at the day before surgery. [ Time Frame: The day before surgery. ]Test score is between 0-100. 100 is the best point and 0 is the worst point in the test. The test has five cognitive domains including attention, memory, language, visuospatial function, and verbal fluency. Patients who score less than 88 in preoperative tests will be diagnosed with mild cognitive impairment.
- Addenbrooke cognitive examination at seventh day after surgery. [ Time Frame: The seventh day after surgery. ]POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores.
- Addenbrooke cognitive examination at third months after surgery. [ Time Frame: The third months after surgery. ]POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores.
- S 100β (pg/mL) [ Time Frame: Change from baseline serum concentration of S 100 β at 6 hours ]Blood S 100β concentration is determined by an enzyme-linked immunosorbent assay kit.
- High Mobility Group Box1 Protein (HMGB1) (ng/mL) [ Time Frame: Change from baseline serum concentration of HMGB1 at 6 hours ]HMGB1 concentration is determined by an enzyme-linked immunosorbent assay kit.
- Human Neuron Specific Enolase (h-NSE) (ng/mL) [ Time Frame: Change from baseline serum concentration of h-NSE at 6 hours ]h-NSE concentration is determined by an enzyme-linked immunosorbent assay kit.
- Interleukine-6 (IL-6) (pg/mL) [ Time Frame: Change from baseline serum concentration of IL-6 at 6 hours ]Blood IL-6 concentration is determined by an enzyme-linked immunosorbent assay kit.
- Postoperative delirium [ Time Frame: Up to postoperative day one ]Postoperative delirium is diagnosed by confusion assessment method.
- Cerebral oxygenation [ Time Frame: During surgery ]Cerebral hypoxia is defined as reduction of regional oxygen saturation by 10 % from baseline before surgery.
- Overall postoperative complications [ Time Frame: Up to postoperative three months. ]Stroke, transient ischemic attack, arrhythmia, heart failure, myocardial injury, respiratory failure, pneumonia, ileus, acute kidney injury, prolonged length of stay, mortality.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837391
|Contact: Emre Şentürk, MDfirstname.lastname@example.org|
|Istanbul, Turkey, 34093|
|Contact: Meltem Savran Karadeniz, Assoc.Prof. +905334845563 email@example.com|
|Study Director:||Meltem Savran Karadeniz, Assoc. Prof.||Istanbul University|