Brain-Induced Neurotrophic Factor Levels in Patients Unde... | NCT04250935

Studies
Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery

NCT04250935

Sponsor

Bozok University

Status

Completed

Last Update Posted

Dec 3, 2020Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Cognitive Dysfunction

Interventions

Patients with cognitive dysfunction

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2020Actual

Primary Completion Date

Aug 15, 2020Actual

Completion Date

Oct 15, 2020Actual

First Submitted Date

Jan 30, 2020

First Submission Date that Met QC Criteria

Jan 30, 2020

First Posted Date

Jan 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2020

Last Update Posted Date

Dec 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In patients undergoing coronary artery bypass surgery, the relationship between neurocognitive changes seen in the early period and brain-induced neurotrophic factor serum levels will be investigated.

Detailed Description

Although postoperative cognitive dysfunction (POKD) is the most common neurological complication in patients undergoing coronary artery bypass grafting (CABG) surgery, its pathophysiology is still not fully understood. However, the quality of this dysfunction has not been properly measured. In addition to clinical tests, biomarkers are often used to detect the presence of POKD. In this study, it was aimed to evaluate the relationship between intraoperative and postoperative brain-derived neurotrophic factor serum levels and POKD in patients undergoing CABG surgery.

This prospective observational study is planned to include 30 adult patients aged 40-90 years. Patients with stroke history, neurodegenerative disease, seizure history, alcohol use, general anxiety, hearing deficit, unilateral carotid artery stenosis greater than 70%, and carotid artery bilateral stenosis greater than 50% will be excluded from the study.

This study aimed to determine perioperative changes in serum brain-derived neurotrophic factor levels in patients undergoing CABG surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with cognitive dysfunction	Diagnostic Test	Mini Mental Test Those with a score below 21 points

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative cognitive dysfunction	Relationship between serum brain-derived neurotrophic factor level and cognitive dysfunction	4 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At Least Primary School Graduates,
Not Using Drugs That May Affect Cognitive Functions,
No Alcohol Substance Use,
Without Psychiatric And Neurological Diseases

Exclusion Criteria:

Uneducated Patients,
Drug Users Who May Affect Cognitive Functions (Antipsychotic, Antidepressant),
Have Alcohol And Substance Use Disorders,
Those With A History Of Central Nervous System Disease That May Cause Cognitive Dysfunction (Such As Stroke, Neurodegenerative Disease, Seizure, General Anxiety),
Hearing Deficit,
Patients With Unilateral Carotid Artery Stenosis Greater Than 70% And Bilateral Stenosis Greater than 50% Carotid Artery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Volunteer patients to be included in the study: 30 adult patients who will undergo coronary artery bypass grafting (CABG) surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yozgat Bozok University Research Hospital	Yozgat	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bozok University Medical Center		Yozgat			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33774438	Derived	Miniksar OH, Cicekcioglu F, Kilic M, Honca M, Miniksar DY, Gocmen AY, Kacmaz O, Oz H. Decreased brain-derived neurotrophic factor levels may predict early perioperative neurocognitive disorder in patients undergoing coronary artery bypass surgery: A prospective observational pilot study. J Clin Anesth. 2021 Aug;71:110235. doi: 10.1016/j.jclinane.2021.110235. Epub 2021 Mar 25.

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders