Clinical trial NCT05742737: Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population
Official title: Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 12000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 12-month all-cause mortality
timeFrame: postoperative 12-month
measure: 6-month all-cause mortality
timeFrame: postoperative 6-month
measure: 1-month all-cause mortality
timeFrame: postoperative 1-month
Secondary outcomes:
measure: Readmission rates
timeFrame: postoperative 30-day
measure: Admission to ICU
timeFrame: From the moment of living operation room to the moment of discharge from hospital,up to 7 day
measure: major complications
timeFrame: From the moment of living operation room to the moment of discharge from hospital,up to 7 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, PhD
role: STUDY_DIRECTOR
References: