Clinical trial NCT04837391: Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)
Official title: Evaluation of the Relationship Between Postoperative Cognitive Dysfunction and Brain Injury Biomarkers In Geriatric Urologic Oncology Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Postoperative Delirium
Frailty
Keywords: postoperative cognitive dysfunction
frailty
S 100β
NSE
IL-6
HMGB-1 protein
NIRS
geriatric anesthesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Addenbrooke cognitive examination at the day before surgery.
timeFrame: The day before surgery.
measure: Addenbrooke cognitive examination at seventh day after surgery.
timeFrame: The seventh day after surgery.
measure: Addenbrooke cognitive examination at third months after surgery.
timeFrame: The third months after surgery.
measure: S 100β (pg/mL)
timeFrame: Change from baseline serum concentration of S 100 β at 6 hours
measure: High Mobility Group Box1 Protein (HMGB1) (ng/mL)
timeFrame: Change from baseline serum concentration of HMGB1 at 6 hours
measure: Human Neuron Specific Enolase (h-NSE) (ng/mL)
timeFrame: Change from baseline serum concentration of h-NSE at 6 hours
measure: Interleukine-6 (IL-6) (pg/mL)
timeFrame: Change from baseline serum concentration of IL-6 at 6 hours
Secondary outcomes:
measure: Postoperative delirium
timeFrame: Up to postoperative day one
measure: Cerebral oxygenation
timeFrame: During surgery
measure: Overall postoperative complications
timeFrame: Up to postoperative three months.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Meltem Savran Karadeniz, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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citation: Plas M, Rotteveel E, Izaks GJ, Spikman JM, van der Wal-Huisman H, van Etten B, Absalom AR, Mourits MJE, de Bock GH, van Leeuwen BL. Cognitive decline after major oncological surgery in the elderly. Eur J Cancer. 2017 Nov;86:394-402. doi: 10.1016/j.ejca.2017.09.024. Epub 2017 Nov 5.
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citation: Fournier A, Krause R, Winterer G, Schneider R. Biomarkers of postoperative delirium and cognitive dysfunction. Front Aging Neurosci. 2015 Jun 9;7:112. doi: 10.3389/fnagi.2015.00112. eCollection 2015.
citation: Li RL, Zhang ZZ, Peng M, Wu Y, Zhang JJ, Wang CY, Wang YL. Postoperative impairment of cognitive function in old mice: a possible role for neuroinflammation mediated by HMGB1, S100B, and RAGE. J Surg Res. 2013 Dec;185(2):815-24. doi: 10.1016/j.jss.2013.06.043. Epub 2013 Jul 17.