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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742737
• Other study ID #: PLAGH-Frailty
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a observational study in China, which aims to explore the predictive effect of preoperative frailty defined by the modified frailty index in predicting postoperative survival and complications in elderly patients.

The objectives of the study include:

1. To demonstrate that the frailty scale can predict short- and long-term survival after surgery in elderly surgical patients; 2 Demonstrated that frailty as defined by this scale is associated with postoperative complications in older patients

Description:

Traditionally, frailty has been described as the form of chronological age. Evaluating the patient's risks based solely on age is difficult, several other factors contribute to physiologic aging and determine functional reserve and response to the risk of postoperative complications. To meet the clinical demand for simpler frailty measurement tools, a simplified 5-index modified frailty index (mFI-5) has been proposed and validated in many literatures. However, there is a lack of evidence on the link between preoperative weakness and poor prognosis in elderly patients undergoing non cardiac surgery.

Therefore, the purpose of this study is to verify the prognostic value of mFI-5 for short-term and long-term adverse outcomes such as postoperative delirium, anxiety, depression, acute pain, and mortality in elderly non-cardiac surgery patients. Our hypothesis is that frailty may be highly correlated with postoperative mortality and adverse outcomes in elderly patients undergoing non-cardiac surgery, and that mFI-5 may be an effective risk prediction tool for decision-making and surgical planning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: April 1, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

(1) participants = 65 years of age;

Exclusion Criteria:

1. lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information);

2. ASA physical status ?;

3. Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia;

4. Surgery time = 60 min.

Related Conditions & MeSH terms

• Frailty

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Weidong Mi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month all-cause mortality	12-month postoperative mortality in elderly patients over 65 years of age	postoperative 12-month
Primary	6-month all-cause mortality	6-month postoperative mortality in elderly patients over 65 years of age	postoperative 6-month
Primary	1-month all-cause mortality	1-month postoperative mortality in elderly patients over 65 years of age	postoperative 1-month
Secondary	Readmission rates	The rate of second admissions in elderly patients over 65 years old who underwent surgery within 30 days after surgery	postoperative 30-day
Secondary	Admission to ICU	Elderly surgical patients over the age of 65 are admitted to the intensive care unit after surgery	From the moment of living operation room to the moment of discharge from hospital,up to 7 day
Secondary	major complications	Postoperative complications include delirium, anxiety, depression, acute pain, stroke, major adverse cardiac events, acute kidney injury, infection, etc	From the moment of living operation room to the moment of discharge from hospital,up to 7 day