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NCT Number: NCT05742737

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 12-month all-cause mortality

    Time frame: postoperative 12-month

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

  2. 6-month all-cause mortality

    Time frame: postoperative 6-month

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

  3. 1-month all-cause mortality

    Time frame: postoperative 1-month

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

Secondary outcomes

  1. Readmission rates

    Time frame: postoperative 30-day

    The rate of second admissions in elderly patients over 65 years old who underwent surgery within 30 days after surgery

  2. Admission to ICU

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

    Elderly surgical patients over the age of 65 are admitted to the intensive care unit after surgery

  3. major complications

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

    Postoperative complications include delirium, anxiety, depression, acute pain, stroke, major adverse cardiac events, acute kidney injury, infection, etc

Sponsors and collaborators

Lead sponsor

Weidong Mi

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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