Study of Postoperative Cognitive Decline in Aged Patients
Relationship Between Postoperative Cognitive Decline and Cytokines in Elderly Patients
1 other identifier
observational
300
1 country
1
Brief Summary
postoperative cognitive decline is a common and deleterious complication in aged patients.The link between inflammation and postoperative cognitive decline has also been reported.However,the link between SOD1，SOD2，Osteopontin， Kallikrein-6，and Contactin-1 and postoperative cognitive decline is unknown. In this project ,investigators examine the relationship between 5 cytokines measured at there timepoints (preoperative \[PREOP\], postoperative day 1 \[POD1\] , and postoperative day 3\[POD2\]) and postoperative cognitive decline among older adults undergoing orthopedic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 2, 2018
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedDecember 5, 2018
December 1, 2018
3 years
December 2, 2018
December 4, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Differences in cytokines levels between the two groups
Compare differences in cytokines levels between the two groups
preoperation
Differences in cytokines levels between the two groups
Compare differences in cytokines levels between the two groups
24h after operation
Differences in cytokines levels between the two groups
Compare differences in cytokines levels between the two groups
72h after operation
Study Arms (2)
POCD group
patients occur cognitive decline after surgery according to scores in this group.
NO POCD group
patients do not occur cognitive decline after surgery according to scores in this group.
Eligibility Criteria
aged patients who recieve surgery for orthopedic surgery under spinal or general anesthesia
You may qualify if:
- patients who are more than 65 years old
- patients who undergo orthopedic surgery(trauma ,especially fracture of lower limb)
- patients with ASA physical status I-III
- patients who have a consent
You may not qualify if:
- patients who are more than 85 years old
- patients with ASA physical status \>III
- patients who have neurological disorders, stroke or other affective central nervous system diseases
- patients who have a history of serious psychiatric illness
- patients with long-term use of psychoactive substances
- patients who undergo multiple trauma and the presence of head injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jia-feng Wanglead
Study Sites (1)
Deartment of anesthesiology,changhai hospital
Shanghai, Shanghai Municipality, 200433, China
Biospecimen
blood of patients is collected preoperation and 24h after surgery and 72h after surgery
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D
Study Record Dates
First Submitted
December 2, 2018
First Posted
December 5, 2018
Study Start
May 1, 2018
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
December 5, 2018
Record last verified: 2018-12