Postoperative Cognitive DysfunctionNCT05406843
Postoperative Cognitive Dysfunction in Heart Surgery
An observational study of Postoperative Cognitive Dysfunction, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
To determine the rate of Postoperative Cognitive Dysfunction (POCD) in the early and late postoperative periods by comparing the preop and postop period mini mental status tests in participants undergoing open heart surgery, and to compare the results of the investgators clinic with the world literature. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Preoperative cognitive functions of participants undergoing open heart surgery and Postoperative cognitive functions of particiants undergoing open heart surgery
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A study was planned on 140 patients undergoing open heart surgery.
Who may be able to join
- 18-75 age
- American Society of Anesthesiologists (ASA) II-III
Who cannot join
- >75 age
- <18 age
- Patients who died within 48 hours after the operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Üniversitesi Tıp Fakültesi Hastanesi
Kocaeli, İzmit, 41100
About this study
Official title: Postoperative Cognitive Dysfunction in Participants Undergoing Open Heart Surgery
To determine the rate of Postoperative Cognitive Dysfunction (POCD) in the early and late postoperative periods by comparing the preop and postop period mini mental status tests in participants undergoing open heart surgery, and to compare the results of the investgators clinic with the world literature.
Read the detailed description
Postoperative delirium (POD) and Cognitive Dysfunction (POCD) are changes in mental status, especially in the geriatric surgery population.Unlike other forms of delirium, POD results in early full recovery.Postoperative Cognitive Dysfunction (POCD) is more difficult to define and implies temporal consciousness impairment associated with surgery.
While the diagnosis of delirium requires the detection of symptoms, the diagnosis of POCD requires preoperative neuropsychological testing and determining how much reduction will mean cognitive dysfunction. Postoperative delirium management is complex and requires multiple strategies. Methods of treating and preventing POCD are still uncertain.It is known that POCD is most commonly seen in patients undergoing open heart surgery.In this study, the investigators aim is to evaluate whether there is any change in cognitive status in the postoperative period compared to the preoperative period of participants who will undergo open heart surgery due to valve pathology or coronary stenosis.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Preoperative cognitive functions of participants undergoing open heart surgery, Postoperative cognitive functions of particiants undergoing open heart surgery
- Keywords
- COGNITIVE DYSFUNCTİON, HEART SURGERY, POSTOPERATIVE DELIRIUM
- Medical subject headings
- Postoperative Cognitive Complications, Cognition Disorders, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative cognitive functions of participants undergoing open heart surgeryOther
Surgery times and cross-clamping times of the participants who will undergo open heart surgery were recorded.
Postoperative cognitive functions of particiants undergoing open heart surgeryOther
Changes in mini mental test scores were recorded in the postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative cognitive status of participants undergoing open heart surgery | Detection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period.
In this study, it was aimed to determine postoperative cognitive impairment by comparing cognitive functions by using Minimental status test in the preoperative period in participants scheduled for open heart surgery for one year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time. Receives: Other: Preoperative cognitive functions of participants undergoing open heart surgery | |
| Postoperative cognitive status of participants undergoing open heart surgery | Detection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period. In this study, it was aimed to determine the postoperative cognitive impairment by comparing it with the cognitive functions in the preoperative period using the Minimental status test in the postoperative period in participants scheduled for open heart surgery for a year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time. Receives: Other: Postoperative cognitive functions of particiants undergoing open heart surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postoperative cognitive functions in participants undergoing open heart surgery.
The aim is to understand whether there is a loss of cognitive functions in the postoperative period, according to the preoperative periods, by testing the participants with open heart surgery on the 3rd day, 7th day, and 2nd month after the surgery.
Measured: 1 year
Secondary outcomes (1)
Comparison with the literature.
Comparison of the results in the investigators clinic with the literature.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huri Yeşildal, Kocaeli University
- Investigators
- Tülay Çardaközü, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406843
- Sponsor's protocol ID
- Observational
- Status last verified
- Jun 2022
- First submitted
- 18 Feb 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction in Participants Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT05406843
- Acronym / sponsor ID
- Observational
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- COGNITIVE DYSFUNCTİON, HEART SURGERY, POSTOPERATIVE DELIRIUM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 7 Jun 2022 (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.
To determine the rate of Postoperative Cognitive Dysfunction (POCD) in the early and late postoperative periods by comparing the preop and postop period mini mental status tests in participants undergoing open heart surgery, and to compare the results of the investgators clinic with the world literature.
Detailed description
Postoperative delirium (POD) and Cognitive Dysfunction (POCD) are changes in mental status, especially in the geriatric surgery population.Unlike other forms of delirium, POD results in early full recovery.Postoperative Cognitive Dysfunction (POCD) is more difficult to define and implies temporal consciousness impairment associated with surgery.
While the diagnosis of delirium requires the detection of symptoms, the diagnosis of POCD requires preoperative neuropsychological testing and determining how much reduction will mean cognitive dysfunction. Postoperative delirium management is complex and requires multiple strategies. Methods of treating and preventing POCD are still uncertain.It is known that POCD is most commonly seen in patients undergoing open heart surgery.In this study, the investigators aim is to evaluate whether there is any change in cognitive status in the postoperative period compared to the preoperative period of participants who will undergo open heart surgery due to valve pathology or coronary stenosis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative cognitive status of participants undergoing open heart surgery | – | Other: Preoperative cognitive functions of participants undergoing open heart surgeryDetection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period. In this study, it was aimed to determine postoperative cognitive impairment by comparing cognitive functions by using Minimental status test in the preoperative period in participants scheduled for open heart surgery for one year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time. |
| Postoperative cognitive status of participants undergoing open heart surgery | – | Other: Postoperative cognitive functions of particiants undergoing open heart surgeryDetection of postoperative cognitive impairment is difficult and it starts with testing in the preoperative period. In this study, it was aimed to determine the postoperative cognitive impairment by comparing it with the cognitive functions in the preoperative period using the Minimental status test in the postoperative period in participants scheduled for open heart surgery for a year. It was planned to compare the obtained data in terms of participants undergoing valve and coronary bypass surgery, age, gender, diabetes, kidney disease, chronic obstructive pulmonary disease (COPD), surgical characteristics, bypass time, and crossclamping time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A study was planned on 140 patients undergoing open heart surgery.
Key inclusion criteria (2 listed)
- 18-75 age
- American Society of Anesthesiologists (ASA) II-III
Key exclusion criteria (3 listed)
- >75 age
- <18 age
- Patients who died within 48 hours after the operation
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 |
|---|---|---|
| Preoperative cognitive functions of participants undergoing open heart surgerySurgery times and cross-clamping times of the participants who will undergo open heart surgery were recorded. | Other | Preoperative cognitive status of participants undergoing open heart surgery |
| Postoperative cognitive functions of particiants undergoing open heart surgeryChanges in mini mental test scores were recorded in the postoperative period. | Other | Postoperative cognitive status of participants undergoing open heart surgery |
Primary outcome
Evaluation of postoperative cognitive functions in participants undergoing open heart surgery.
Time frame: 1 year
The aim is to understand whether there is a loss of cognitive functions in the postoperative period, according to the preoperative periods, by testing the participants with open heart surgery on the 3rd day, 7th day, and 2nd month after the surgery.
1 secondary outcome
Comparison with the literature.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Yes. all collected individual participant data
Related trials for Postoperative Cognitive Dysfunction
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
Not yet recruitingObservational study
Impact of Preoperative Mild Cognitive Impairment on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Neurocognitive Disorder, Cardiac Surgery
RecruitingObservational study
Post Operative Cognitive Dysfunction After Oncologic Surgery
Emergence Delirium, Post-Operative Cognitive Dysfunction
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.
Tülay Çardaközü study director
Kocaeli 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, run by Kocaeli 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of postoperative cognitive functions in participants undergoing open heart surgery. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2022.