Cognitive DeclineNCT03765840
Study of Postoperative Cognitive Decline in Aged Patients
An observational study of Cognitive Decline, run by Jia-feng Wang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: aged patients who recieve surgery for orthopedic surgery under spinal or general anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Deartment of anesthesiology,changhai hospital
Shanghai, Shanghai Municipality, 200433
Xi-Ya Yu, M.D., +86-21-31161841, yuxiyash@163.com
Xi-Ya Yu, M.D.
About this study
Official title: 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.
- Conditions
- Cognitive Decline
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Differences in cytokines levels between the two groups
Compare differences in cytokines levels between the two groups
Measured: preoperation
Differences in cytokines levels between the two groups
Compare differences in cytokines levels between the two groups
Measured: 24h after operation
Differences in cytokines levels between the two groups
Compare differences in cytokines levels between the two groups
Measured: 72h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 May 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jia-feng Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia-feng Wang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765840
- Sponsor's protocol ID
- POCD-aged
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Postoperative Cognitive Decline and Cytokines in Elderly Patients
- ClinicalTrials.gov ID
- NCT03765840
- Acronym / sponsor ID
- POCD-aged
- Conditions
- Cognitive Decline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jia-feng WangUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- aged patients who recieve surgery for orthopedic surgery under spinal or general anesthesia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in cytokines levels between the two groups
Time frame: preoperation
Compare differences in cytokines levels between the two groups
Differences in cytokines levels between the two groups
Time frame: 24h after operation
Compare differences in cytokines levels between the two groups
Differences in cytokines levels between the two groups
Time frame: 72h after operation
Compare differences in cytokines levels between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline, run by Jia-feng Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wenbin lu (86+21-31161841, 13004162573@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in cytokines levels between the two groups (time frame: preoperation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.