Association Between Iron Reserves and Perioperative Neuro... | NCT06502912

Studies
Association Between Iron Reserves and Perioperative Neurocognitive Disorders

NCT06502912

Sponsor

Chinese PLA General Hospital

Status

Completed

Last Update Posted

Jul 16, 2024Actual

Enrollment

12,984Actual

Phase

Not provided

Conditions

Perioperative Neurocognitive Disorders

Interventions

no intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jul 2, 2024

First Submission Date that Met QC Criteria

Jul 9, 2024

First Posted Date

Jul 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2024

Last Update Posted Date

Jul 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weidong Mi, Director (Cheif expert of National key research and development program of China 2018YFC2001900), Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,984Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
elderly patients (aged ≥ 65 years)		elderly patients undergoing non-neurosurgical and non-cardiac procedures	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	elderly patients (aged ≥ 65 years)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Within the first seven days following surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Geriatric surgical patients ≥65 years old

Exclusion Criteria:

preoperative use of antipsychotics
diagnosis or history description of preoperative cognitive disorders including dementia and Parkinson's

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

hospital based group

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Weidong Mi, PhD	Chinese PLA General Hospital	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019190	Iron Overload

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided