Postoperative Cognitive DysfunctionPOCDNCT04837391
Postoperative Cognitive Dysfunction in Elderly Urologic Oncology Patients (POCD)
An observational study of Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium, Frailty
- What is being tested?
- Near Infrared Spectroscopy (NIRS), Blood sample and Addenbrooke Cognitive Examination III (ACE-III)
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2020to 21 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Patients over the age of 65 who are planned to undergo major urooncological surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Istanbul, 34093
Meltem Savran Karadeniz, Assoc.Prof., +905334845563, mskaradeniz@gmail.com
About this study
Official title: 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)].
Read the 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.
- Being tested
- Near Infrared Spectroscopy (NIRS), Blood sample, Addenbrooke Cognitive Examination III (ACE-III), Confusion Assessment Method
- Keywords
- postoperative cognitive dysfunction, frailty, S 100β, NSE, IL-6, HMGB-1 protein, NIRS, geriatric anesthesia
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy (NIRS)Device
Also called INVOS Cerebral Oximeter 5100C (Covidien Dublin, Ireland)
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.
Blood sampleDiagnostic 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.
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.
Confusion Assessment MethodDiagnostic test
Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.
| Study group | Role | What they receive |
|---|---|---|
| Urologic oncology surgery in elderly | Elective urologic oncology surgeries such as radical nephrectomy, radical cystectomy, radical prostatectomy in older than 65 years Receives: Device: Near Infrared Spectroscopy (NIRS); Diagnostic Test: Blood sample; Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III); Diagnostic Test: Confusion Assessment Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The third months after surgery.
S 100β (pg/mL)
Blood S 100β concentration is determined by an enzyme-linked immunosorbent assay kit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline serum concentration of IL-6 at 6 hours
Secondary outcomes (3)
Postoperative delirium
Postoperative delirium is diagnosed by confusion assessment method.
Measured: Up to postoperative day one
Cerebral oxygenation
Cerebral hypoxia is defined as reduction of regional oxygen saturation by 10 % from baseline before surgery.
Measured: During surgery
Overall postoperative complications
Stroke, transient ischemic attack, arrhythmia, heart failure, myocardial injury, respiratory failure, pneumonia, ileus, acute kidney injury, prolonged length of stay, mortality.
Measured: Up to postoperative three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 Apr 2020
- Primary completion21 May 2021 (estimated)
- Study completion21 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, Assoc. Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837391
- Sponsor's protocol ID
- 2019/1555
- Acronym
- POCD
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30072128Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
PubMed 24622758Plas 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.
PubMed 29100194Kapoor 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.
PubMed 31485127Fournier 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.
PubMed 26106326Li 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.
PubMed 23899512
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Postoperative Cognitive Dysfunction and Brain Injury Biomarkers In Geriatric Urologic Oncology Patients
- ClinicalTrials.gov ID
- NCT04837391
- Acronym / sponsor ID
- POCD / 2019/1555
- Keywords
- postoperative cognitive dysfunction, frailty, S 100β, NSE, IL-6, HMGB-1 protein, NIRS, geriatric anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 21 May 2021 (estimated)
- Study completion
- 21 Jul 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urologic oncology surgery in elderly | – | Device: Near Infrared Spectroscopy (NIRS), Diagnostic Test: Blood sample, Diagnostic Test: Addenbrooke Cognitive Examination III (ACE-III), Diagnostic Test: Confusion Assessment MethodElective urologic oncology surgeries such as radical nephrectomy, radical cystectomy, radical prostatectomy in older than 65 years |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients over the age of 65 who are planned to undergo major urooncological surgery.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared Spectroscopy (NIRS)Also: INVOS Cerebral Oximeter 5100C (Covidien Dublin, Ireland)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. | Device | Urologic oncology surgery in elderly |
| Blood sampleBlood 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 | Urologic oncology surgery in elderly |
| 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 | Urologic oncology surgery in elderly |
| Confusion Assessment MethodConfusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium. | Diagnostic test | Urologic oncology surgery in elderly |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Postoperative delirium
Time frame: Up to postoperative day one
Cerebral oxygenation
Time frame: During surgery
Overall postoperative complications
Time frame: Up to postoperative three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 30072128Yanagisawa 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.
- Background: PubMed 24622758Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
- Background: PubMed 29100194Plas 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.
- Background: PubMed 31485127Kapoor 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.
- Background: PubMed 26106326Fournier 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.
- Background: PubMed 23899512Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meltem Savran Karadeniz, Assoc. Prof. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emre Şentürk, MD (+905326114062, dr.emresentrk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Addenbrooke cognitive examination at the day before surgery. (time frame: The day before surgery.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837391, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.