Association of Frailty and Delirium in Elderly Hip Fracture Patients

NCT05246254 | Unknown

• 1 other identifier: BTCH-MZ-007
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium in Old Age; Frailty

Keywords

frailty; postoperative delirium; hip fracture; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Duration of delirium

  Postoperative 7 days

• Delirium drug use

  Postoperative 7 days

• Length of hospital stay (HLOS)

  Postoperative 30 days

• Length of ICU stay

  Postoperative 30 days

• Hospital cost

  Postoperative 30 days

Study Arms (3)

Prefrailty group

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

Diagnostic Test: Frailty index scale

Frailty group

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

Diagnostic Test: Frailty index scale

Nonfrailty group

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

Diagnostic Test: Frailty index scale

Interventions

Frailty index scale DIAGNOSTIC_TEST

There are clinically common scales for assessing weakness and delirium.

Also known as: CAM scale, Nu-DESC sclae

Frailty group; Nonfrailty group; Prefrailty group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 65 who underwent surgery for hip fractures

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Beijing Municipal Administration of Hospitals: collaborator

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 100018, China

RECRUITING

MeSH Terms

Conditions

Frailty; Emergence Delirium; Hip Fractures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Huan Zhang, PhD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Zhang, PhD

CONTACT

(010)17600809297; whta01956@btch.edu.cn

Haotian Wu, MD

CONTACT

(010)56119357; tatabox@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 18, 2022
• Study Start: February 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-02

Locations

CN (1)