C-reactive Protein，Homocysteine，Postoperative Delirium
C-reactive Protein and Homocysteine and Their Interaction Contribute to Postoperative Delirium
1 other identifier
observational
150
1 country
1
Brief Summary
The aim of this study is to evaluate how C-reactive protein (CRP) and homocysteine and their interaction contribute to postoperative delirium, based on our previous finding on the interactions of CRP, homocysteine and postoperative delirium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
December 21, 2021
CompletedStudy Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJanuary 11, 2022
December 1, 2021
2 years
September 10, 2021
December 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative delirium
Incidence of postoperative delirium on postoperative day 1, 2 and 3 will be defined according to the confusion assessment methods (CAM).
3 days after surgery
Secondary Outcomes (1)
Severity of postoperative delirium
3 days after surgery
Other Outcomes (2)
Pain Scores
3 days after surgery
Sleep difficulty
3 days after surgery
Eligibility Criteria
Patients 60 years old or older and scheduled for orthopedic surgeries with an expected duration ≥ 2 h
You may qualify if:
- were 60 years old or older
- had a normal cognitive function at the time of enrollment, evidenced by a mini-mental state examination (MMSE) score above an education-adjusted threshold (18 for individuals with no school education, 20 for 1-6 years of education, or 24 for 7 or more years of education 27)
- spoke Mandarin Chinese
- were able to provide informed consent
- scheduled for orthopaedic surgeries
You may not qualify if:
- pre-existing delirium assessed according to the Confusion Assessment Method (CAM) algorithm;
- prior neurologic diseases (Parkinson's disease, multiple sclerosis or stroke) according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10);
- history of mental disorders, e.g., major depressive disorder and schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV);
- unwillingness to comply with the assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai 10th People's Hospitallead
- Tongji Hospitalcollaborator
Study Sites (1)
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan Shen, MD, PhD
Shanghai, Shanghai, China, 200072
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Psychiatry
Study Record Dates
First Submitted
September 10, 2021
First Posted
December 21, 2021
Study Start
January 10, 2022
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
January 11, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share