NCT06502912

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,984

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

8 years

First QC Date

July 2, 2024

Last Update Submit

July 9, 2024

Conditions

Keywords

iron reservesPerioperative neurocognitive disorderselderlyiron overload

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

elderly patients (aged ≥ 65 years)

elderly patients undergoing non-neurosurgical and non-cardiac procedures

Other: no intervention

Interventions

no intervention

elderly patients (aged ≥ 65 years)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital based group

You may qualify if:

  • Geriatric surgical patients ≥65 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Weidong Mi, PhD

    Chinese PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 16, 2024

Study Start

January 1, 2014

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 16, 2024

Record last verified: 2024-07