Discovery for Biomarkers and Risk Factors for Postoperative Delirium in Elderly Patients With Spine Surgery

NCT ID: NCT04120272

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2021-10-31

Brief Summary

Introduction: With the increase of the elderly population, the number of elderly patients undergoing surgery is increasing, and postoperative delirium is 11-51% depending on the type of surgery. In recent cohort studies have shown that delirium might reduce cognitive function and develop dementia.

Since delirium is difficult to treat, the key to treatment is prevention, and about 40% is prevented when prophylactic intervention is applied. However, delirium is difficult to diagnose and difficult to predict, therefore, biomarkers are needed to diagnose and prevention.

Exosome and brain efficiency test(electroencephalogram, and pulse wave test) have the potential of simple biomarkers that can diagnose postoperative delirium and predict cognitive decline.

Purpose: The purpose of this study is to investigate the risk factors affecting delirium in the elderly who have spinal surgery and to search for biomarkers of delirium for early detection and prevention of delirium.

Detailed Description

Method:

1. Study design: This study is a prospective investigation that identifies risk factors for postoperative delirium and searches for predictive biomarkers of delirium.

2. Inclusion criteria / Exclusion Criteria

1. Inclusion criteria

• Elderly patients over 70
• Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery

2. Exclusion Criteria

• Patients with cognitive decline according to MMSE-DS outcome criterion
• Patients diagnosed with malignant or benign tumors
• If surgery is scheduled within 2 hours(micro surgery)
• In case of difficulty in communication
• History of brain neurological diseases (brain hemorrhage, stroke, dementia, Parkinson's, cognitive impairment diagnosis, etc.)
• Patients diagnosed with alcoholism or drug addiction
• Patients with surgical complications (post-operative bleeding, high fever over 39 degrees, etc.)
• Patients undergoing re-operation due to surgery-related complications

3. Outcome

1. Primary outcome: Urinary and Blood exosome, stool

2. Secondary outcome: brain function test(electroencephalogram, pulse wave test, and cognitive test)

4. Measurement

1. Delirium: Confusion Assessment Method(CAM), Korean-Delirium Rating Scale-R-98(K-DRS-R-98), Korean Nusing Delirium Scale(Nu-DESC)

2. Cognitive function test: Mini-Mental State Examination-Dementia Screening(MMSE-DS), Montreal Cognitive Assessment(MoCA), Telephone interview for Cognitive Status(TICS)

3. Depression: Geriatric Depression Scale Short Form Version (GDSSF-K)

4. Activity Daily of Living: K-ADL, K-IADL

5. Frail: Korean version of the FRAIL scale

6. Nutrition: Mini Nutritional Assessment-Short Form

7. patient-reported outcomes ; PROMIS-29

Conditions

Spinal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Delirium group

Group of patients with postoperative delirium

Spine surgery

Intervention Type: PROCEDURE

Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery

Non delirium group

Group of patients without postoperative delirium

Spine surgery

Intervention Type: PROCEDURE

Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery

Interventions

Spine surgery

Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Elderly patients over 70

2. Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery

Exclusion Criteria

1. Patients with cognitive decline according to MMSE-DS outcome criterion

2. Patients diagnosed with malignant or benign tumors

3. If surgery is scheduled within 2 hours(micro surgery)

4. In case of difficulty in communication

5. History of brain neurological diseases (brain hemorrhage, stroke, dementia, Parkinson's, cognitive impairment diagnosis, etc.)

6. Patients diagnosed with alcoholism or drug addiction

7. Patients with surgical complications (post-operative bleeding, high fever over 39 degrees, etc.)

8. Patients undergoing re-operation due to surgery-related complications

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Bon-Nyeo Koo, MD, PhD

Role: CONTACT

koobn@yuhs.ac

82-2-2228-2422

Facility Contacts

Bon-Nyeo Koo, MD, PhD

Role: primary

koobn@yuhs.ac

82-2-2228-2422

Other Identifiers

4-2019-0654

Identifier Type: -

Identifier Source: org_study_id