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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03765840
Other study ID # POCD-aged
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date May 2021

Study information

Verified date December 2018
Source Changhai Hospital
Contact wenbin lu
Phone 86+21-31161841
Email 13004162573@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Deartment of anesthesiology,changhai hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jia-feng Wang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in cytokines levels between the two groups Compare differences in cytokines levels between the two groups preoperation
Primary Differences in cytokines levels between the two groups Compare differences in cytokines levels between the two groups 24h after operation
Primary Differences in cytokines levels between the two groups Compare differences in cytokines levels between the two groups 72h after operation
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