NCT04120272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

September 29, 2019

Last Update Submit

June 3, 2021

Conditions

Spinal Disease

Outcome Measures

Primary Outcomes (9)

  • Exosomes in Urine: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    Just before surgery

  • Exosomes in Urine: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    just before end of surgery

  • Exosomes in Urine: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    Post operative day 1 (6 AM)

  • Exosomes in Urine: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    Post operative day 1 (6 PM)

  • Exosomes in Urine: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    immediately after onset of delirium

  • Exosomes in Urine: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    7 days after surgery, within hospitalization period

  • Exosomes in Blood: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    Just before surgery

  • Exosomes in Blood: Differences in Gene Expression

    \- Gene expression and expression comparison in exosomes The gene expression difference is determined using the SAM tool and DEseq2, and the Gene Ontology (GO) Database (www.geneontology.org) and the KEGG database (www.genome.jp/kegg) are used to find the correlation between gene functions. In the case of miRNA, there will be a regulatory function of the coding gene, so for this purpose, an integrative analysis is performed to identify the mRNA-miRNA interaction

    just before end of surgery

  • Fecal microbiota

    just before surgery, on the day of discharge

Secondary Outcomes (20)

  • Brain efficiency test(EEG)

    Before surgery (from 2 weeks before to the day before)

  • Brain efficiency test(pulse wave test)

    Before surgery (from 2 weeks before to the day before)

  • Cognitive test -MMSE

    Before surgery (from 2 weeks before to the day before)

  • Cognitive test -MOCA

    Before surgery (from 2 weeks before to the day before)

  • Cognitive test -TICS

    Before surgery (from 2 weeks before to the day before)

  • +15 more secondary outcomes

Study Arms (2)

Delirium group

Group of patients with postoperative delirium

Procedure: Spine surgery

Non delirium group

Group of patients without postoperative delirium

Procedure: Spine surgery

Interventions

Spine surgeryPROCEDURE

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

Delirium groupNon delirium group

Eligibility Criteria

Age70 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary hospital, single institution

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gene expression and expression comparison in exosomes

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Bon-Nyeo Koo, MD, PhD

CONTACT

82-2-2228-2422koobn@yuhs.ac

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 9, 2019

Study Start

October 21, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

June 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)