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Association of Frailty and Delirium in Elderly Hip Fracture Patients

The Association of Preoperative Frailty Index and Incidence of Postoperative Delirium in Elderly Patients With Hip Fracture: a Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05246254
Enrollment
300
Registered
2022-02-18
Start date
2022-02-01
Completion date
2024-12-30
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium in Old Age, Frailty

Keywords

frailty, postoperative delirium, hip fracture, elderly

Brief summary

Several studies have shown that frailty can be used as a marker for risk of adverse outcomes in elderly patients such as falls, disability, hospitalization, mortality, and can be used to predict patient clinical outcomes. The purpose of this study is to determine whether preoperative frailty can be used as a diagnostic and predictive factor for postoperative delirium in elderly patients with hip fracture.

Detailed description

Frailty index (FI) is a reliable method to determine the assessment of frailty in elderly patients. Multiple prospective cohort studies have shown that frailty can be used as a marker for risk of adverse outcomes in older adults such as falls, disability, hospitalization, and mortality, and can be used to predict patient clinical outcomes. Whether frailty could be used as a diagnostic and predictive factor for delirium is urgently needed in a large population. Therefore, this project intends to conduct a prospective cohort study. Patients will be divided into three groups according to frailty index (FI) before surgery, and delirium status will be evaluated by using scales after surgery, so as to explore the diagnostic and predictive value of frailty on POD. Once confirmed, the results of this study will be helpful for the early identification, screening, diagnosis and evaluation of treatment effect of POD. It is of great scientific significance and social benefit to reduce the incidence of POD, improve the prognosis of vulnerable patients and reduce the burden of disease.

Interventions

DIAGNOSTIC_TESTFrailty index scale

There are clinically common scales for assessing weakness and delirium.

Sponsors

Beijing Municipal Administration of Hospitals
CollaboratorOTHER_GOV
Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The subjects were patients with hip fracture; * Older than 65 years; * Patients signed informed consent; * American Society of Anesthesiologist (ASA) Rated I- III; * The surgery was performed by the same anesthesia and surgical team.

Exclusion criteria

* Patients cannot sign the consent form or refuse to participate; * A history of cognitive impairment; * Unable to complete the cognitive function test; * Mental disorder during initial assessment; * Patients suffering from mental illness or substance use disorder; * Incomplete or lost data during follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative delirium(POD) in elderly patients with hip fracturePostoperative 7 daysThe percentage of the study population who developed delirium within seven days of surgery,postoperative delirium(POD) is defined according to the CAM criterion

Secondary

MeasureTime frameDescription
Length of ICU stayPostoperative 30 daysCollection of clinical data in the medical record
Hospital costPostoperative 30 daysExpenses during hospitalization
Duration of deliriumPostoperative 7 daysThe time between the first appearance of delirium
Length of hospital stay (HLOS)Postoperative 30 daysCollection of clinical data in the medical record
Dindo-Clavien Classification{References:Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240(2):205-213.}Postoperative 30 daysIncidence of serious adverse reactions within 30 days after operation (the therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge are highlighted in the present classification by a suffix (d for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.)
Death before and 30 days after discharge30 days after dischargeCollection of clinical data in the medical record and follow-up update through telephone
Delirium drug usePostoperative 7 daysdosage and name of medication prescribed by a neurologist

Countries

China

Contacts

Primary ContactHuan Zhang, PhD
whta01956@btch.edu.cn(010)17600809297
Backup ContactHaotian Wu, MD
tatabox@163.com(010)56119357

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026