Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)

Frailty Clinical Trial

— POCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837391
• Other study ID #: 2019/1555
• Status: Recruiting
• Start date: April 21, 2020
• Est. completion date: July 21, 2021

Study information

• Verified date: April 2021
• Source: Istanbul University
• Contact: Emre Sentürk, MD
• Phone: +905326114062
• Email: dr.emresentrk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)].

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Frailty
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Intervention

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.

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.
• 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.
• Confusion Assessment Method
Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Androsova G, 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. Review. — View Citation

Kapoor I, Prabhakar H, Mahajan C. Postoperative Cognitive Dysfunction. Indian J Crit Care Med. 2019 Jun;23(Suppl 2):S162-S164. doi: 10.5005/jp-journals-10071-23196. Review. — View 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. — View 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. — View Citation

Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119. Review. — View Citation

Yanagisawa R, Tanaka M, Yashima F, Arai T, Kohno T, Shimizu H, Fukuda K, Naganuma T, Mizutani K, Araki M, Tada N, Yamanaka F, Shirai S, Tabata M, Ueno H, Takagi K, Higashimori A, Watanabe Y, Yamamoto M, Hayashida K. Frequency and Consequences of Cognitive Impairmentin Patients Underwent Transcatheter Aortic Valve Implantation. Am J Cardiol. 2018 Sep 1;122(5):844-850. doi: 10.1016/j.amjcard.2018.05.026. Epub 2018 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Addenbrooke cognitive examination at 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.
Primary	Addenbrooke cognitive examination at seventh day after surgery.	POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores.	The seventh day after surgery.
Primary	Addenbrooke cognitive examination at third months after surgery.	POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores.	The third months after surgery.
Primary	S 100ß (pg/mL)	Blood S 100ß concentration is determined by an enzyme-linked immunosorbent assay kit.	Change from baseline serum concentration of S 100 ß at 6 hours
Primary	High Mobility Group Box1 Protein (HMGB1) (ng/mL)	HMGB1 concentration is determined by an enzyme-linked immunosorbent assay kit.	Change from baseline serum concentration of HMGB1 at 6 hours
Primary	Human Neuron Specific Enolase (h-NSE) (ng/mL)	h-NSE concentration is determined by an enzyme-linked immunosorbent assay kit.	Change from baseline serum concentration of h-NSE at 6 hours
Primary	Interleukine-6 (IL-6) (pg/mL)	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	Postoperative delirium	Postoperative delirium is diagnosed by confusion assessment method.	Up to postoperative day one
Secondary	Cerebral oxygenation	Cerebral hypoxia is defined as reduction of regional oxygen saturation by 10 % from baseline before surgery.	During surgery
Secondary	Overall postoperative complications	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.