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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05742737
Enrollment
12000
Registered
2023-02-24
Start date
2020-04-01
Completion date
2023-04-01
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

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

Detailed 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.

Interventions

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

Sponsors

Weidong Mi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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 Ⅴ; 3. Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia; 4. Surgery time ≤ 60 min.

Design outcomes

Primary

MeasureTime frameDescription
12-month all-cause mortalitypostoperative 12-month12-month postoperative mortality in elderly patients over 65 years of age
6-month all-cause mortalitypostoperative 6-month6-month postoperative mortality in elderly patients over 65 years of age
1-month all-cause mortalitypostoperative 1-month1-month postoperative mortality in elderly patients over 65 years of age

Secondary

MeasureTime frameDescription
Readmission ratespostoperative 30-dayThe rate of second admissions in elderly patients over 65 years old who underwent surgery within 30 days after surgery
Admission to ICUFrom the moment of living operation room to the moment of discharge from hospital,up to 7 dayElderly surgical patients over the age of 65 are admitted to the intensive care unit after surgery
major complicationsFrom the moment of living operation room to the moment of discharge from hospital,up to 7 dayPostoperative complications include delirium, anxiety, depression, acute pain, stroke, major adverse cardiac events, acute kidney injury, infection, etc

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026