Association of Frailty and Delirium in Elderly Hip Fracture Patients

Recruiting

• Conditions: Delirium in Old Age; Frailty
• Interventions: Diagnostic Test: Frailty index scale

• Registration Number: NCT05246254
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Study Timeline

• Study First Submitted: 2022-01-12
• Study Start: 2022-02-01
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nonfrailty group	Frailty index scale	According to the frailty index(FI) and FI\<0.12
Frailty group	Frailty index scale	According to the frailty index(FI) and FI≥ 0.25
Prefrailty group	Frailty index scale	According to the frailty index(FI) and FI =0.12\~0.25

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium（POD） in elderly patients with hip fracture	Postoperative 7 days	The percentage of the study population who developed delirium within seven days of surgery,postoperative delirium（POD） is defined according to the CAM criterion

Secondary Outcome Measures

Name	Time	Method
Duration of delirium	Postoperative 7 days	The time between the first appearance of delirium
Length of hospital stay (HLOS)	Postoperative 30 days	Collection of clinical data in the medical record
Length of ICU stay	Postoperative 30 days	Collection of clinical data in the medical record
Hospital cost	Postoperative 30 days	Expenses during hospitalization
Death before and 30 days after discharge	30 days after discharge	Collection of clinical data in the medical record and follow-up update through telephone
Delirium drug use	Postoperative 7 days	dosage and name of medication prescribed by a neurologist
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 days	Incidence 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.）

Trial Locations

Locations (1)

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China