Association of Frailty and Delirium in Elderly Hip Fracture Patients

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246254
• Other study ID #: BTCH-MZ-007
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Huan Zhang, PhD
• Phone: (010)17600809297
• Email: whta01956[@]btch.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Frailty
• Hip Fractures

Intervention

Diagnostic Test:
• Frailty index scale
There are clinically common scales for assessing weakness and delirium.

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital	Beijing Municipal Administration of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium(POD) in elderly patients with hip fracture	The percentage of the study population who developed delirium within seven days of surgery,postoperative delirium(POD) is defined according to the CAM criterion	Postoperative 7 days
Secondary	Duration of delirium	The time between the first appearance of delirium	Postoperative 7 days
Secondary	Delirium drug use	dosage and name of medication prescribed by a neurologist	Postoperative 7 days
Secondary	Length of hospital stay (HLOS)	Collection of clinical data in the medical record	Postoperative 30 days
Secondary	Length of ICU stay	Collection of clinical data in the medical record	Postoperative 30 days
Secondary	Hospital cost	Expenses during hospitalization	Postoperative 30 days
Secondary	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.}	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.)	Postoperative 30 days
Secondary	Death before and 30 days after discharge	Collection of clinical data in the medical record and follow-up update through telephone	30 days after discharge