Perioperative Neurocognitive DisordersNCT06502912
Association Between Iron Reserves and Perioperative Neurocognitive Disorders
An observational study of Perioperative Neurocognitive Disorders, run by Chinese PLA General Hospital.
Trial summary
Iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. However, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perioperative Neurocognitive Disorders
- How many people
- 12,984 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: hospital based group
Who may be able to join
- Geriatric surgical patients ≥65 years old
Who cannot join
- preoperative use of antipsychotics
- diagnosis or history description of preoperative cognitive disorders including dementia and Parkinson's
About this study
Iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. However, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. This retrospective cohort study aimed to explore the impact of preoperative serum ferritin levels on the risk of postoperative delirium in elderly patients undergoing non-neurosurgical and non-cardiac procedures.
- Conditions
- Perioperative Neurocognitive Disorders
- Being tested
- no intervention
- Keywords
- iron reserves, Perioperative neurocognitive disorders, elderly, iron overload
- Medical subject headings
- Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| elderly patients (aged ≥ 65 years) | elderly patients undergoing non-neurosurgical and non-cardiac procedures Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative delirium
Medical chart review was used for postoperative delirium determination in this study. The defining criteria were as follows: 1) delirium-related terms included in postoperative medical records or 2) postoperative record of delirium or psychotropic drugs treatment.
Measured: Within the first seven days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jan 2014
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, PhD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502912
- Sponsor's protocol ID
- PLAGH-AOC-R02
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Iron Reserves and Perioperative Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT06502912
- Acronym / sponsor ID
- PLAGH-AOC-R02
- Conditions
- Perioperative Neurocognitive Disorders
- Keywords
- iron reserves, Perioperative neurocognitive disorders, elderly, iron overload
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,984 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Jul 2024 (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.
Iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. However, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. This retrospective cohort study aimed to explore the impact of preoperative serum ferritin levels on the risk of postoperative delirium in elderly patients undergoing non-neurosurgical and non-cardiac procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly patients (aged ≥ 65 years) | – | Other: no interventionelderly patients undergoing non-neurosurgical and non-cardiac procedures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- hospital based group
Key inclusion criteria (1 listed)
- Geriatric surgical patients ≥65 years old
Key exclusion criteria (2 listed)
- preoperative use of antipsychotics
- diagnosis or history description of preoperative cognitive disorders including dementia and Parkinson's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | elderly patients (aged ≥ 65 years) |
Primary outcome
Number of participants with postoperative delirium
Time frame: Within the first seven days following surgery
Medical chart review was used for postoperative delirium determination in this study. The defining criteria were as follows: 1) delirium-related terms included in postoperative medical records or 2) postoperative record of delirium or psychotropic drugs treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Weidong Mi, PhD study chair
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Neurocognitive Disorders, run by Chinese PLA General Hospital.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative delirium (time frame: Within the first seven days following surgery). 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 16 Jul 2024.