Study of Postoperative Cognitive Decline in Aged Patients

December 4, 2018 updated by: Jia-feng Wang

Relationship Between Postoperative Cognitive Decline and Cytokines in Elderly Patients

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Deartment of anesthesiology,changhai hospital
        • Contact:
        • Principal Investigator:
          • Xi-Ya Yu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

aged patients who recieve surgery for orthopedic surgery under spinal or general anesthesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in cytokines levels between the two groups
Time Frame: preoperation
Compare differences in cytokines levels between the two groups
preoperation
Differences in cytokines levels between the two groups
Time Frame: 24h after operation
Compare differences in cytokines levels between the two groups
24h after operation
Differences in cytokines levels between the two groups
Time Frame: 72h after operation
Compare differences in cytokines levels between the two groups
72h after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jia-feng Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

December 2, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POCD-aged

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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