Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population

Sponsor

Weidong Mi (Other)

Overall Status

Completed

CT.gov ID

NCT05742737

Collaborator

(none)

50,000

Enrollment

Location

Actual Duration (Months)

4169.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Frailty is becoming an increasingly established risk factor for adverse postoperative outcomes. Given the high incidence of complications after total joint arthroplasty and the propensity for comorbidities in older patients, it would be necessary to evaluate frailty status of patients by using a 5-factor modified frailty index (mFI-5) as a predictor of adverse events.

Condition or Disease	Intervention/Treatment	Phase
Frailty	Other: Frailty Index

Study Design

Study Type:

Observational

Actual Enrollment :

50000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population: a Retrospective Cohort Study

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Nov 1, 2022

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
no frailty	Other: Frailty Index The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database
low frailty	Other: Frailty Index The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database
medium frailty	Other: Frailty Index The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database
high frailty	Other: Frailty Index The mFI-5 scoring system used in the current study was developed by Saxton and Velanovich by comparing the five variables in the original CSHA-FI with NSQIP database

Outcome Measures

Primary Outcome Measures

one-year all-cause mortality [postoperative 1 year]

Secondary Outcome Measures

one-month readmission rates [postoperative 1 month]
major complications [From the moment of living operation room to the moment of discharge from hospital,up to 7 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

(1) participants ≥ 65 years of age;

Exclusion Criteria:

lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information);
ASA physical status Ⅴ;
Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia;
Surgery time ≤ 60 min.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China

Sponsors and Collaborators

Weidong Mi

Investigators

Study Director: Weidong Mi, PhD, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weidong Mi, Director of anesthesiology department, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT05742737

Other Study ID Numbers:

PLAGH-Frailty

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Frailty

Study Results

No Results Posted as of Feb 24, 2023