Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)

NCT04837391 | Unknown

• 1 other identifier: 2019/1555
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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 \[S100 β, neuron specific enolase (NSE), interleukin 6 (IL-6) and high mobility group box-1 (HMGB-1 protein)\].

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium; Frailty

Keywords

postoperative cognitive dysfunction; frailty; S 100β; NSE; IL-6; HMGB-1 protein; NIRS; geriatric anesthesia

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• S 100β (pg/mL)

  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)

  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)

  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)

  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 Outcomes (3)

• Postoperative delirium

  Up to postoperative day one

• Cerebral oxygenation

  During surgery

• Overall postoperative complications

  Up to postoperative three months.

Study Arms (1)

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); Diagnostic Test: Blood sample; Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III); Diagnostic Test: Confusion Assessment Method

Interventions

Near Infrared Spectroscopy (NIRS) DEVICE

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.

Also known as: INVOS Cerebral Oximeter 5100C (Covidien Dublin, Ireland)

Urologic oncology surgery in elderly

Blood sample DIAGNOSTIC_TEST

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.

Urologic oncology surgery in elderly

Addenbrooke Cognitive Examination III (ACE-III) DIAGNOSTIC_TEST

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.

Urologic oncology surgery in elderly

Confusion Assessment Method DIAGNOSTIC_TEST

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

Urologic oncology surgery in elderly

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 30072128 BACKGROUND

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

  PMID: 24622758 BACKGROUND

• 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.

  PMID: 29100194 BACKGROUND

• 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.

  PMID: 31485127 BACKGROUND

• 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.

  PMID: 26106326 BACKGROUND

• 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.

  PMID: 23899512 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium; Frailty

Interventions

Spectroscopy, Near-Infrared; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Meltem Savran Karadeniz, Assoc. Prof.

  Istanbul University

  STUDY DIRECTOR

Central Study Contacts

Emre Şentürk, MD

CONTACT

+905326114062; dr.emresentrk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 8, 2021
• Study Start: April 21, 2020
• Primary Completion: May 21, 2021
• Study Completion: July 21, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)