Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD) (POCD)

April 6, 2021 updated by: Meltem Savran Karadeniz, Istanbul University

Evaluation of the Relationship Between Postoperative Cognitive Dysfunction and Brain Injury Biomarkers In Geriatric Urologic Oncology Patients

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)].

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Recruiting
        • Istanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The day before surgery.
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.
The seventh day after surgery.
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.
The third months after surgery.
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.
Change from baseline serum concentration of S 100 β at 6 hours
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.
Change from baseline serum concentration of HMGB1 at 6 hours
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.
Change from baseline serum concentration of h-NSE at 6 hours
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.
Change from baseline serum concentration of IL-6 at 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative delirium
Time Frame: Up to postoperative day one
Postoperative delirium is diagnosed by confusion assessment method.
Up to postoperative day one
Cerebral oxygenation
Time Frame: During surgery
Cerebral hypoxia is defined as reduction of regional oxygen saturation by 10 % from baseline before surgery.
During 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.
Up to postoperative three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Meltem Savran Karadeniz, Assoc. Prof., Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Anticipated)

May 21, 2021

Study Completion (Anticipated)

July 21, 2021

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/1555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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