Clinical trial NCT05246254: Association of Frailty and Delirium in Elderly Hip Fracture Patients
Official title: The Association of Preoperative Frailty Index and Incidence of Postoperative Delirium in Elderly Patients With Hip Fracture: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium in Old Age
Frailty
Keywords: frailty
postoperative delirium
hip fracture
elderly
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospitals
First posted: 2022-02-18
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 65 who underwent surgery for hip fractures

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative delirium（POD） in elderly patients with hip fracture
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: Duration of delirium
timeFrame: Postoperative 7 days
measure: Delirium drug use
timeFrame: Postoperative 7 days
measure: Length of hospital stay (HLOS)
timeFrame: Postoperative 30 days
measure: Length of ICU stay
timeFrame: Postoperative 30 days
measure: Hospital cost
timeFrame: Postoperative 30 days
measure: 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.}
timeFrame: Postoperative 30 days
measure: Death before and 30 days after discharge
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Huan Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: