Association of Frailty and Delirium in Elderly Hip Fracture Patients

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246254
Collaborator
Beijing Municipal Administration of Hospitals (Other)
300
1
34.9
8.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Frailty index scale

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
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Association of Preoperative Frailty Index and Incidence of Postoperative Delirium in Elderly Patients With Hip Fracture: a Prospective Cohort Study
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Prefrailty group

According to the frailty index(FI) and FI =0.12~0.25

Diagnostic Test: Frailty index scale
There are clinically common scales for assessing weakness and delirium.
Other Names:
  • CAM scale
  • Nu-DESC sclae
  • Frailty group

    According to the frailty index(FI) and FI≥ 0.25

    Diagnostic Test: Frailty index scale
    There are clinically common scales for assessing weakness and delirium.
    Other Names:
  • CAM scale
  • Nu-DESC sclae
  • Nonfrailty group

    According to the frailty index(FI) and FI<0.12

    Diagnostic Test: Frailty index scale
    There are clinically common scales for assessing weakness and delirium.
    Other Names:
  • CAM scale
  • Nu-DESC sclae
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Duration of delirium [Postoperative 7 days]

      The time between the first appearance of delirium

    2. Delirium drug use [Postoperative 7 days]

      dosage and name of medication prescribed by a neurologist

    3. Length of hospital stay (HLOS) [Postoperative 30 days]

      Collection of clinical data in the medical record

    4. Length of ICU stay [Postoperative 30 days]

      Collection of clinical data in the medical record

    5. Hospital cost [Postoperative 30 days]

      Expenses during hospitalization

    6. 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.)

    7. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tsinghua Changgung Hospital Beijing Beijing China 100018

    Sponsors and Collaborators

    • Beijing Tsinghua Chang Gung Hospital
    • Beijing Municipal Administration of Hospitals

    Investigators

    • Principal Investigator: Huan Zhang, PhD, Beijing Tsinghua Changgeng Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Tsinghua Chang Gung Hospital
    ClinicalTrials.gov Identifier:
    NCT05246254
    Other Study ID Numbers:
    • BTCH-MZ-007
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Beijing Tsinghua Chang Gung Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022