Association of Plasma Biomarkers for Neurological Injury... | NCT04194411

Studies
Association of Plasma Biomarkers for Neurological Injury and Postoperative Delirium After Cardiac Surgery

NCT04194411

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 10, 2022Actual

Enrollment

152Actual

Phase

Not provided

Conditions

Postoperative Delirium

Interventions

Not provided

Countries

South Korea

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

Jan 2022

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 7, 2020Actual

Primary Completion Date

Dec 8, 2021Actual

Completion Date

Dec 8, 2021Actual

First Submitted Date

Dec 9, 2019

First Submission Date that Met QC Criteria

Dec 9, 2019

First Posted Date

Dec 11, 2019Actual

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

Jan 6, 2022

Last Update Posted Date

Jan 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Delirium is one of the most common complications after cardiac surgeries, incidence of which is 20~70%. Causes and pathophysiology of delirium has not been elucidated yet, however, inflammatory response of the nervous system, imbalance of neurotransmitters and ischemia-reperfusion injury of brain tissue are thought to play a big role.

'Neurofilament light (Nfl)' and 'Tau' are proteins that comprise neurons, which are released into blood during acute brain injury. Increased serum concentrations of these markers are acknowledged to be associated with worse clinical outcomes in patients with acute brain injury. These proteins are also closely linked to degenerative changes in the nervous system and cognitive decline in Alzheimer's disease. Therefore, the increase in blood levels of 'Nfl' and 'Tau' may be related to the development of delirium.

The aim of this study is to investigate the association between 'Nfl' and 'Tau', serum markers of damage of the nervous system, and the development of delirium after cardiac surgery.

Detailed Description

Assessment of cognitive function and delirium Before the day before surgery, K-MMSE (Korean version of Mini-Mental State Exam) is conducted to check the subjects' baseline cognitive function.

From the postoperative day 0 to 7, CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) for mechanically ventilated patients, or 3D-CAM (3-minute diagnostic assessment for delirium using the Confusion Assessment Method) for extubated patients is performed twice a day to assess whether delirium occurs. Records of the nurses are also checked.
Measurement of the serum levels of Nfl and Tau Serum concentrations of Nfl and Tau are measured after anesthetic induction, and at postoperative 6 hours

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

Retention

Enrollment

152Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Valve surgery		Patients older than 65 years and undergoing elective valvular heart surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative delirium	From the postoperative day 0 to 7, CAM-ICU (for mechanically ventilated patients) or 3D-CAM (for extubated patients) is performed twice a day. Electronic medical records of the patients are also assessed.	Postoperative 7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Patients undergoing valvular heart surgery (>65 years old)

Exclusion Criteria:

1. Emergency operation
2. Patients with drug or alcohol abuse
3. Patients with major depressive disorder, major neurocognitive disorder or schizophrenia
4. Patients with schizophrenia
5. Patients who are not able to communicate verbally

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients undergoing valvular heart surgery (>65 years old)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium
C537987	Charcot-Marie-Tooth disease, Type 1F
D020774	Pick Disease of the Brain
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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