Spinal DiseaseNCT04120272
Discovery for Biomarkers and Risk Factors for Postoperative Delirium in Elderly Patients With Spine Surgery
An observational study of Spinal Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Oct 2019to Oct 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Tertiary hospital, single institution
Who may be able to join
- Elderly patients over 70
- Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Bon-Nyeo Koo, MD, PhD, 82-2-2228-2422, koobn@yuhs.ac
About this study
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.
Read more
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.
Read the detailed description
Method:
- Study design: This study is a prospective investigation that identifies risk factors for postoperative delirium and searches for predictive biomarkers of delirium.
- Inclusion criteria / Exclusion Criteria
- Inclusion criteria
- Elderly patients over 70
- Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery
- 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
- Outcome
- Primary outcome: Urinary and Blood exosome, stool
- Secondary outcome: brain function test(electroencephalogram, pulse wave test, and cognitive test)
- Measurement
- Delirium: Confusion Assessment Method(CAM), Korean-Delirium Rating Scale-R-98(K-DRS-R-98), Korean Nusing Delirium Scale(Nu-DESC)
- Cognitive function test: Mini-Mental State Examination-Dementia Screening(MMSE-DS), Montreal Cognitive Assessment(MoCA), Telephone interview for Cognitive Status(TICS)
- Depression: Geriatric Depression Scale Short Form Version (GDSSF-K)
- Activity Daily of Living: K-ADL, K-IADL
- Frail: Korean version of the FRAIL scale
- Nutrition: Mini Nutritional Assessment-Short Form
- patient-reported outcomes ; PROMIS-29
- Conditions
- Spinal Disease
- Being tested
- Spine surgery
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine surgeryProcedure or surgery
Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery
| Study group | Role | What they receive |
|---|---|---|
| Delirium group | Group of patients with postoperative delirium Receives: Procedure: Spine surgery | |
| Non delirium group | Group of patients without postoperative delirium Receives: Procedure: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: just before end of surgery
Fecal microbiota
Measured: just before surgery, on the day of discharge
Secondary outcomes (20)
Brain efficiency test(EEG)
- EEG test for brain efficiency Peak-MEF(intermediate rhythm of background EEG spectrum), Peak-Freq, Peak_power, Theta frequency band (4 or more and less than 8) of the left (Fp1) EEG power value (log scale), Left (Fp1) EEG alpha frequency band (8 or more and less than 12) Power value (log scale), Left (Fp1) EEG slow beta band (more than 12 and less than 15) power value (log scale), Left (Fp1) EEG mid-beta frequency band (more than 15 and less than 20) power value (log scale), Fast beta frequency band of the left (Fp1) brain waves (more than 20 and less than 30) power value (log scale), Gamma frequency band (30 or more and 50 or less) power value (log scale) of left (Fp1) brain waves, Peak amplitude of 125 Hz auditory stimulated brain potential (ERP); Left and right average of P2 (maximum) peak value difference based on N1 (minimum) peak. Peak amplitude mean of left (Fp1) auditory induced brain potentials (ERPs), Left and right EEG cross-correlation coefficient.
Measured: Before surgery (from 2 weeks before to the day before)
Brain efficiency test(pulse wave test)
- pulse wave test for brain efficiency HF (High Frequency) frequency band of heart rate variability (RRV) (0.15 or more and 0.4Hz or less), LF (Low Frequency) frequency band of heart rate variability (RRV) (0.04 or more and less than 0.15 Hz) absolute power, Relative percentage of LF to (LF + HF), Total power of heart rate variability (RRV), Heart rate variability (RRV) histogram; the histogram distribution area divided by the maximum value
Measured: Before surgery (from 2 weeks before to the day before)
Cognitive test -MMSE
Measured: Before surgery (from 2 weeks before to the day before)
Cognitive test -MOCA
Measured: Before surgery (from 2 weeks before to the day before)
Cognitive test -TICS
Measured: Before surgery (from 2 weeks before to the day before)
Brain efficiency test(EEG)
- EEG test for brain efficiency Peak-MEF(intermediate rhythm of background EEG spectrum), Peak-Freq, Peak_power, Theta frequency band (4 or more and less than 8) of the left (Fp1) EEG power value (log scale), Left (Fp1) EEG alpha frequency band (8 or more and less than 12) Power value (log scale), Left (Fp1) EEG slow beta band (more than 12 and less than 15) power value (log scale), Left (Fp1) EEG mid-beta frequency band (more than 15 and less than 20) power value (log scale), Fast beta frequency band of the left (Fp1) brain waves (more than 20 and less than 30) power value (log scale), Gamma frequency band (30 or more and 50 or less) power value (log scale) of left (Fp1) brain waves, Peak amplitude of 125 Hz auditory stimulated brain potential (ERP); Left and right average of P2 (maximum) peak value difference based on N1 (minimum) peak. Peak amplitude mean of left (Fp1) auditory induced brain potentials (ERPs), Left and right EEG cross-correlation coefficient.
Measured: 7 days after surgery, within hospitalization period
Brain efficiency test(pulse wave test)
- pulse wave test for brain efficiency HF (High Frequency) frequency band of heart rate variability (RRV) (0.15 or more and 0.4Hz or less), LF (Low Frequency) frequency band of heart rate variability (RRV) (0.04 or more and less than 0.15 Hz) absolute power, Relative percentage of LF to (LF + HF), Total power of heart rate variability (RRV), Heart rate variability (RRV) histogram; the histogram distribution area divided by the maximum value
Measured: 7 days after surgery, within hospitalization period
Cognitive test -MMSE
Measured: 7 days after surgery, within hospitalization period
Cognitive test -MOCA
Measured: 7 days after surgery, within hospitalization period
Cognitive test -TICS
Measured: 7 days after surgery, within hospitalization period
Brain efficiency test(EEG)
- EEG test for brain efficiency Peak-MEF(intermediate rhythm of background EEG spectrum), Peak-Freq, Peak_power, Theta frequency band (4 or more and less than 8) of the left (Fp1) EEG power value (log scale), Left (Fp1) EEG alpha frequency band (8 or more and less than 12) Power value (log scale), Left (Fp1) EEG slow beta band (more than 12 and less than 15) power value (log scale), Left (Fp1) EEG mid-beta frequency band (more than 15 and less than 20) power value (log scale), Fast beta frequency band of the left (Fp1) brain waves (more than 20 and less than 30) power value (log scale), Gamma frequency band (30 or more and 50 or less) power value (log scale) of left (Fp1) brain waves, Peak amplitude of 125 Hz auditory stimulated brain potential (ERP); Left and right average of P2 (maximum) peak value difference based on N1 (minimum) peak. Peak amplitude mean of left (Fp1) auditory induced brain potentials (ERPs), Left and right EEG cross-correlation coefficient.
Measured: 1 month after surgery
Brain efficiency test(pulse wave test)
- pulse wave test for brain efficiency HF (High Frequency) frequency band of heart rate variability (RRV) (0.15 or more and 0.4Hz or less), LF (Low Frequency) frequency band of heart rate variability (RRV) (0.04 or more and less than 0.15 Hz) absolute power, Relative percentage of LF to (LF + HF), Total power of heart rate variability (RRV), Heart rate variability (RRV) histogram; the histogram distribution area divided by the maximum value
Measured: 1 month after surgery
Cognitive test -MMSE
Measured: 1 month after surgery
Cognitive test -MOCA
Measured: 1 month after surgery
Cognitive test -TICS
Measured: 1 month after surgery
Brain efficiency test(EEG)
- EEG test for brain efficiency Peak-MEF(intermediate rhythm of background EEG spectrum), Peak-Freq, Peak_power, Theta frequency band (4 or more and less than 8) of the left (Fp1) EEG power value (log scale), Left (Fp1) EEG alpha frequency band (8 or more and less than 12) Power value (log scale), Left (Fp1) EEG slow beta band (more than 12 and less than 15) power value (log scale), Left (Fp1) EEG mid-beta frequency band (more than 15 and less than 20) power value (log scale), Fast beta frequency band of the left (Fp1) brain waves (more than 20 and less than 30) power value (log scale), Gamma frequency band (30 or more and 50 or less) power value (log scale) of left (Fp1) brain waves, Peak amplitude of 125 Hz auditory stimulated brain potential (ERP); Left and right average of P2 (maximum) peak value difference based on N1 (minimum) peak. Peak amplitude mean of left (Fp1) auditory induced brain potentials (ERPs), Left and right EEG cross-correlation coefficient.
Measured: 1 year after surgery
Brain efficiency test(pulse wave test)
- pulse wave test for brain efficiency HF (High Frequency) frequency band of heart rate variability (RRV) (0.15 or more and 0.4Hz or less), LF (Low Frequency) frequency band of heart rate variability (RRV) (0.04 or more and less than 0.15 Hz) absolute power, Relative percentage of LF to (LF + HF), Total power of heart rate variability (RRV), Heart rate variability (RRV) histogram; the histogram distribution area divided by the maximum value
Measured: 1 year after surgery
Cognitive test -MMSE
Measured: 1 year after surgery
Cognitive test -MOCA
Measured: 1 year after surgery
Cognitive test -TICS
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start21 Oct 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120272
- Sponsor's protocol ID
- 4-2019-0654
- Status last verified
- Jun 2021
- First submitted
- 29 Sep 2019
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery for Biomarkers and Risk Factors for Postoperative Delirium in Elderly Patients With Spine Surgery
- ClinicalTrials.gov ID
- NCT04120272
- Acronym / sponsor ID
- 4-2019-0654
- Conditions
- Spinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 9 Oct 2019 (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.
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:
- Study design: This study is a prospective investigation that identifies risk factors for postoperative delirium and searches for predictive biomarkers of delirium.
- Inclusion criteria / Exclusion Criteria
- Inclusion criteria
- Elderly patients over 70
- Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery
- 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
- Outcome
- Primary outcome: Urinary and Blood exosome, stool
- Secondary outcome: brain function test(electroencephalogram, pulse wave test, and cognitive test)
- Measurement
- Delirium: Confusion Assessment Method(CAM), Korean-Delirium Rating Scale-R-98(K-DRS-R-98), Korean Nusing Delirium Scale(Nu-DESC)
- Cognitive function test: Mini-Mental State Examination-Dementia Screening(MMSE-DS), Montreal Cognitive Assessment(MoCA), Telephone interview for Cognitive Status(TICS)
- Depression: Geriatric Depression Scale Short Form Version (GDSSF-K)
- Activity Daily of Living: K-ADL, K-IADL
- Frail: Korean version of the FRAIL scale
- Nutrition: Mini Nutritional Assessment-Short Form
- patient-reported outcomes ; PROMIS-29
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium group | – | Procedure: Spine surgeryGroup of patients with postoperative delirium |
| Non delirium group | – | Procedure: Spine surgeryGroup of patients without postoperative delirium |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Tertiary hospital, single institution
Key inclusion criteria (2 listed)
- Elderly patients over 70
- Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery
Key exclusion criteria (8 listed)
- 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.)
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 |
|---|---|---|
| Spine surgeryEligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery | Procedure or surgery | Delirium group, Non delirium group |
Primary outcome
Exosomes in Urine: Differences in Gene Expression
Time frame: Just before surgery
- 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
Exosomes in Urine: Differences in Gene Expression
Time frame: just before end of surgery
- 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
Exosomes in Urine: Differences in Gene Expression
Time frame: Post operative day 1 (6 AM)
- 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
Exosomes in Urine: Differences in Gene Expression
Time frame: Post operative day 1 (6 PM)
- 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
Exosomes in Urine: Differences in Gene Expression
Time frame: immediately after onset of delirium
- 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
Exosomes in Urine: Differences in Gene Expression
Time frame: 7 days after surgery, within hospitalization period
- 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
Exosomes in Blood: Differences in Gene Expression
Time frame: Just before surgery
- 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
Exosomes in Blood: Differences in Gene Expression
Time frame: just before end of surgery
- 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
Fecal microbiota
Time frame: just before surgery, on the day of discharge
20 secondary outcomes
Brain efficiency test(EEG)
Time frame: Before surgery (from 2 weeks before to the day before)
Brain efficiency test(pulse wave test)
Time frame: Before surgery (from 2 weeks before to the day before)
Cognitive test -MMSE
Time frame: Before surgery (from 2 weeks before to the day before)
Cognitive test -MOCA
Time frame: Before surgery (from 2 weeks before to the day before)
Cognitive test -TICS
Time frame: Before surgery (from 2 weeks before to the day before)
Brain efficiency test(EEG)
Time frame: 7 days after surgery, within hospitalization period
Brain efficiency test(pulse wave test)
Time frame: 7 days after surgery, within hospitalization period
Cognitive test -MMSE
Time frame: 7 days after surgery, within hospitalization period
Cognitive test -MOCA
Time frame: 7 days after surgery, within hospitalization period
Cognitive test -TICS
Time frame: 7 days after surgery, within hospitalization period
Brain efficiency test(EEG)
Time frame: 1 month after surgery
Brain efficiency test(pulse wave test)
Time frame: 1 month after surgery
Cognitive test -MMSE
Time frame: 1 month after surgery
Cognitive test -MOCA
Time frame: 1 month after surgery
Cognitive test -TICS
Time frame: 1 month after surgery
Brain efficiency test(EEG)
Time frame: 1 year after surgery
Brain efficiency test(pulse wave test)
Time frame: 1 year after surgery
Cognitive test -MMSE
Time frame: 1 year after surgery
Cognitive test -MOCA
Time frame: 1 year after surgery
Cognitive test -TICS
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No
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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.
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 Spinal Disease, run by Yonsei University at 1 site in South Korea.
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 8 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bon-Nyeo Koo, MD, PhD (82-2-2228-2422, koobn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exosomes in Urine: Differences in Gene Expression (time frame: Just before surgery). The study lists 9 primary outcomes in all. 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 7 Jun 2021.