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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
Sponsor:
Information provided by (Responsible Party):
Meltem Savran Karadeniz, Istanbul University

Brief Summary:
Postoperative cognitive changes are more common in elderly patients, which can result in poor quality of life, loss of workforce, disability, early retirement, physical-social dependence, increased health care cost and premature mortality. Postoperative cognitive complications are also quite common in extensive oncological surgeries. 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 [S100 β, neuron specific enolase (NSE), interleukin 6 (IL-6) and high mobility group box-1 (HMGB-1 protein)].

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

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. Postoperative delirium [ Time Frame: Up to postoperative day one ]
    Postoperative delirium is diagnosed by confusion assessment method.

  2. Cerebral oxygenation [ Time Frame: During surgery ]
    Cerebral hypoxia is defined as reduction of regional oxygen saturation by 10 % from baseline before surgery.

  3. 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
Blood samples are collected from study participants after anesthesia induction and after the end of the operation.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over the age of 65 who are planned to undergo major urooncological surgery (radical nephrectomy, radical prostatectomy and radical cystectomy) as of April 21, 2020 at the Istanbul University Hospital are included in the study.
Criteria

Inclusion Criteria:

  • Patients over the age of 65 who are planned to undergo major urooncological surgery.

Exclusion Criteria:

  • Patients who refuse to participate in the study.
  • Patients with severe hearing-vision problems.
  • Patients with serious neurological-psychiatric disorders.
  • Patients with language barrier.
  • Patients with missing in any interventions.
  • Patients with blood samples that are not suitable for the ELISA.

Information from the National Library of Medicine

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


Contacts
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Contact: Emre Şentürk, MD +905326114062 dr.emresentrk@gmail.com

Locations
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Turkey
Istanbul University Recruiting
Istanbul, Turkey, 34093
Contact: Meltem Savran Karadeniz, Assoc.Prof.    +905334845563    mskaradeniz@gmail.com   
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Meltem Savran Karadeniz, Assoc. Prof. Istanbul University
Publications:

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Responsible Party: Meltem Savran Karadeniz, Associate Professor, Istanbul University
ClinicalTrials.gov Identifier: NCT04837391    
Other Study ID Numbers: 2019/1555
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meltem Savran Karadeniz, Istanbul University:
postoperative cognitive dysfunction
frailty
S 100β
NSE
IL-6
HMGB-1 protein
NIRS
geriatric anesthesia
Additional relevant MeSH terms:
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Delirium
Frailty
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Cognition Disorders