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Clinical Trials/NCT04837391
NCT04837391
Unknown
N/A

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

Istanbul University1 site in 1 country48 target enrollmentApril 21, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Cognitive Dysfunction
Sponsor
Istanbul University
Enrollment
48
Locations
1
Primary Endpoint
Addenbrooke cognitive examination at the day before surgery.
Last Updated
5 years ago

Overview

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)].

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.

Registry
clinicaltrials.gov
Start Date
April 21, 2020
End Date
July 21, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meltem Savran Karadeniz

Associate Professor

Istanbul University

Eligibility 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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

  • Cerebral oxygenation(During surgery)
  • Overall postoperative complications(Up to postoperative three months.)
  • Postoperative delirium(Up to postoperative day one)

Study Sites (1)

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