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Clinical Trials/NCT05246254
NCT05246254RecruitingNot Applicable

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

Beijing Tsinghua Chang Gung Hospital1 site in 1 country300 target enrollmentStarted: February 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
Incidence of postoperative delirium(POD) in elderly patients with hip fracture

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Incidence of postoperative delirium(POD) in elderly patients with hip fracture

Time Frame: 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 Outcomes

  • Duration of delirium(Postoperative 7 days)
  • Length of hospital stay (HLOS)(Postoperative 30 days)
  • Length of ICU stay(Postoperative 30 days)
  • Hospital cost(Postoperative 30 days)
  • Death before and 30 days after discharge(30 days after discharge)
  • Delirium drug use(Postoperative 7 days)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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