Clinical trial NCT04120272: Discovery for Biomarkers and Risk Factors for Postoperative Delirium in Elderly Patients With Spine Surgery
Official title: Discovery for Biomarkers and Risk Factors for Postoperative Delirium in Elderly Patients With Spine Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 600
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary hospital, single institution

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

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

Primary outcomes:
measure: Exosomes in Urine: Differences in Gene Expression
timeFrame: Just before surgery
measure: Exosomes in Urine: Differences in Gene Expression
timeFrame: just before end of surgery
measure: Exosomes in Urine: Differences in Gene Expression
timeFrame: Post operative day 1 (6 AM)
measure: Exosomes in Urine: Differences in Gene Expression
timeFrame: Post operative day 1 (6 PM)
measure: Exosomes in Urine: Differences in Gene Expression
timeFrame: immediately after onset of delirium
measure: Exosomes in Urine: Differences in Gene Expression
timeFrame: 7 days after surgery, within hospitalization period
measure: Exosomes in Blood: Differences in Gene Expression
timeFrame: Just before surgery
measure: Exosomes in Blood: Differences in Gene Expression
timeFrame: just before end of surgery
measure: Fecal microbiota
timeFrame: just before surgery, on the day of discharge
Secondary outcomes:
measure: Brain efficiency test(EEG)
timeFrame: Before surgery (from 2 weeks before to the day before)
measure: Brain efficiency test(pulse wave test)
timeFrame: Before surgery (from 2 weeks before to the day before)
measure: Cognitive test -MMSE
timeFrame: Before surgery (from 2 weeks before to the day before)
measure: Cognitive test -MOCA
timeFrame: Before surgery (from 2 weeks before to the day before)
measure: Cognitive test -TICS
timeFrame: Before surgery (from 2 weeks before to the day before)
measure: Brain efficiency test(EEG)
timeFrame: 7 days after surgery, within hospitalization period
measure: Brain efficiency test(pulse wave test)
timeFrame: 7 days after surgery, within hospitalization period
measure: Cognitive test -MMSE
timeFrame: 7 days after surgery, within hospitalization period
measure: Cognitive test -MOCA
timeFrame: 7 days after surgery, within hospitalization period
measure: Cognitive test -TICS
timeFrame: 7 days after surgery, within hospitalization period
measure: Brain efficiency test(EEG)
timeFrame: 1 month after surgery
measure: Brain efficiency test(pulse wave test)
timeFrame: 1 month after surgery
measure: Cognitive test -MMSE
timeFrame: 1 month after surgery
measure: Cognitive test -MOCA
timeFrame: 1 month after surgery
measure: Cognitive test -TICS
timeFrame: 1 month after surgery
measure: Brain efficiency test(EEG)
timeFrame: 1 year after surgery
measure: Brain efficiency test(pulse wave test)
timeFrame: 1 year after surgery
measure: Cognitive test -MMSE
timeFrame: 1 year after surgery
measure: Cognitive test -MOCA
timeFrame: 1 year after surgery
measure: Cognitive test -TICS
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References: