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

NCT05742737 | Completed

• 1 other identifier: PLAGH-Frailty
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Frailty

Outcome Measures

Primary Outcomes (3)

• 12-month all-cause mortality

  12-month postoperative mortality in elderly patients over 65 years of age

  postoperative 12-month

• 6-month all-cause mortality

  6-month postoperative mortality in elderly patients over 65 years of age

  postoperative 6-month

• 1-month all-cause mortality

  1-month postoperative mortality in elderly patients over 65 years of age

  postoperative 1-month

Secondary Outcomes (3)

• Readmission rates

  postoperative 30-day

• Admission to ICU

  From the moment of living operation room to the moment of discharge from hospital,up to 7 day

• major complications

  From the moment of living operation room to the moment of discharge from hospital,up to 7 day

Study Arms (3)

Robust

Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.

Prefrail

Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.

Other: Frailty Index

frail

Unlike previous frailty index, mFI-5 uses a small number of variables readily available in a patient's history, including functional status (partial or complete dependence), history of diabetes, COPD, congestive heart failure, and hypertension requiring medication. 1 point is assigned to each variable. Functional status refers to needing some or all of the assistance of others in daily activities, including bathing, eating, dressing, going to the toilet, moving, traveling, and more. The mFI-5 score was calculated by increasing the number of variables per patient Patients were divided into 3 groups based on their mFI-5: frail group (mFI-5, 2-5) , prefrail group (mFI-5, 1) and robust group (mFI-5, 0). The range of the mFI-5 is from 0 to 5 with increments of 1, and increasing the mFI-5 implies increasing frailty.

Other: Frailty Index

Interventions

Frailty Index OTHER

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

Prefrail; frail

Eligibility Criteria

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

Study Population

The lack of sufficient study data, however, does not demonstrate a dose-response relationship, with higher frailty levels having a greater impact on mortality \[9\]. Accordingly, this article would focus on the relationship between patients with varying degrees of frailty and long-term postoperative adverse outcomes and how preoperative planning and interventions can alter surgical trajectories and associated outcomes. According to our hypothesis, preoperative frailty can provide prognostic information, in addition to frequently recognized risks and consequences.

You may qualify if:

• (1) participants ≥ 65 years of age;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weidong Mi: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of anesthesiology department

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 24, 2023
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 1, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)