Postoperative InfectionsNCT06985771
Predictive Ability of Different Frailty Indices for Postoperative Infections in Elderly Patients
An observational study of Postoperative Infections and Frailty, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In this study, we extracted data from the patients medical record within the cohort to compare five existing frailty indices: the 5-Item Modified Frailty Index (mFI-5), the Electronic Frailty Index (eFI), the Frailty Index based on Comprehensive Geriatric Assessment (FI-CGA), the Frailty Risk Assessment Instrument for… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Infections, Frailty
- How many people
- 10,536 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 6 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The patients aged 65 and older who were involved in the prospective cohort of postoperative adverse events in elderly patients from April 2020 to April 2022.
Who may be able to join
- Aged 65 and above
- Patients who underwent Non-Cardiac surgeries and anesthesia
Who cannot join
- Patients who underwent surgery within 30 days before the current procedure;
- Patients with missing baseline demographic data;
- Patients with incomplete medical records that resulted in the inability to fully assess all five frailty indices;
- Patients with missing data related to primary and secondary outcomes after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100857
About this study
Official title: Evaluating the Predictive Ability of Different Frailty Indices for Postoperative Infections in Elderly Patients: Data Analysis From a Prospective Multicenter Observational Cohort
In this study, we extracted data from the patients medical record within the cohort to compare five existing frailty indices: the 5-Item Modified Frailty Index (mFI-5), the Electronic Frailty Index (eFI), the Frailty Index based on Comprehensive Geriatric Assessment (FI-CGA), the Frailty Risk Assessment Instrument for the Elderly based on Laboratory and Clinical Indicators (FRAIL), and the Hospital Frailty Risk Score (HFRS). The study aims to evaluate the predictive values of each electronic frailty index for the incidence of postoperative infection-related adverse events. This includes the primary outcome of infection events occurring within 30 days and the secondary outcome of the correlations among the five frailty indices.
- Conditions
- Postoperative Infections, Frailty
- Being tested
- Observational study, with no intervention.
- Keywords
- Frailty, Postoperative Infection, elderly patients
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, with no intervention.Other
Observational study, with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative infection or not | Postoperative infection within 30 days postoperatively versus no infection. Receives: Other: Observational study, with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative infection events within 30 days postoperatively
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Mar 2025
- Primary completion10 Apr 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative InfectionsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10,536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Medical Center of Chinese PLA General Hospital
- Responsible party
- Principal investigator, Jingsheng Lou, Chinese PLA General Hospital
- Investigators
- Jingsheng Lou, Doctor, Principal investigator, The First Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985771
- Sponsor's protocol ID
- PLAGH-AOC-L08
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Predictive Ability of Different Frailty Indices for Postoperative Infections in Elderly Patients: Data Analysis From a Prospective Multicenter Observational Cohort
- ClinicalTrials.gov ID
- NCT06985771
- Acronym / sponsor ID
- PLAGH-AOC-L08
- Conditions
- Postoperative Infections, Frailty
- Keywords
- Frailty, Postoperative Infection, elderly patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,536 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- The First Medical Center of Chinese PLA General Hospital
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we extracted data from the patients medical record within the cohort to compare five existing frailty indices: the 5-Item Modified Frailty Index (mFI-5), the Electronic Frailty Index (eFI), the Frailty Index based on Comprehensive Geriatric Assessment (FI-CGA), the Frailty Risk Assessment Instrument for the Elderly based on Laboratory and Clinical Indicators (FRAIL), and the Hospital Frailty Risk Score (HFRS). The study aims to evaluate the predictive values of each electronic frailty index for the incidence of postoperative infection-related adverse events. This includes the primary outcome of infection events occurring within 30 days and the secondary outcome of the correlations among the five frailty indices.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative infection or not | – | Other: Observational study, with no intervention.Postoperative infection within 30 days postoperatively versus no infection. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The patients aged 65 and older who were involved in the prospective cohort of postoperative adverse events in elderly patients from April 2020 to April 2022.
Key inclusion criteria (2 listed)
- Aged 65 and above
- Patients who underwent Non-Cardiac surgeries and anesthesia
Key exclusion criteria (4 listed)
- Patients who underwent surgery within 30 days before the current procedure;
- Patients with missing baseline demographic data;
- Patients with incomplete medical records that resulted in the inability to fully assess all five frailty indices;
- Patients with missing data related to primary and secondary outcomes after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, with no intervention.Observational study, with no intervention. | Other | Postoperative infection or not |
Primary outcome
Postoperative infection events within 30 days postoperatively
Time frame: Within 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingsheng Lou, Doctor principal investigator
The First Medical Center of Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Infections and Frailty, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative infection events within 30 days postoperatively (time frame: Within 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.