Postoperative InfectionNCT06265493
Postoperative Infectious Complications Calculator for Elderly Patients
An observational study of Postoperative Infection and Geriatrics, run by Weidong Mi at 1 site in China.
Trial summary
The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Infection, Geriatrics, Prediction
- How many people
- 37,230 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Sep 2023
- 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: A total of 37230 participants were included in the derivation and internal validation cohorts (29785 in the derivation cohort and 7445 in the internal validation cohort).
Who may be able to join
- age ≥ 65 years and
- patients undergoing surgery with anesthesia.
Who cannot join
- patients undergoing neurosurgery or cardiac surgery,
- preoperative infectious diseases, and
- patients with ≥50% of data missing.
Trial locations and contacts
1 site in 1 country.
China1 site
Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: Postoperative Infectious Complications Calculator for Elderly Patients--A Derivation and External Validation of Prediction Models Based on Two Centers Large Sample
The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections.
Read the detailed description
Background:
Postoperative infectious complications (PICs) are related to increased morbidity, mortality, and costs, especially in elderly patients. However, published prediction models of PICs are rarely based on elderly patients.
Objective:
The study wanted to identify practical and valuable variables that could be used to predict postoperative infections and establish a convenient scoring system for clinicians to assess the risk of such conditions in elderly patients.
Methods： Data from 2 population-based cohorts of elderly patients undergoing non-cardiac and non-neurology surgery were used to derive and validate multivariable logistic regression models. The risk prediction models were derived from 37230 patients hospitalized in the First Medical Center of the Chinese PLA General Hospital (January 2012 - August 2018). The risk prediction models were externally validated with data from a cohort of 10252 patients hospitalized in Henan Provincial People's Hospital (November 2014 to May 2022).
- Conditions
- Postoperative Infection, Geriatrics, Prediction
- Keywords
- postoperative infectious complications, elderly patients, retrospective study, prediction model, calculator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| derivation cohort | 29785 in the derivation cohort | |
| internal validation cohort | 7445 in the internal validation cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Infectious Complications Calculator for Elderly Patients
A Derivation and External Validation of Prediction Models based on two centers large sample
Measured: January 2012 - August 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jun 2021
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weidong Mi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, Ph.D., Study chair, Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265493
- Sponsor's protocol ID
- PLAGH-AOC-L02
- Status last verified
- Sep 2024
- First submitted
- 11 Feb 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Infectious Complications Calculator for Elderly Patients--A Derivation and External Validation of Prediction Models Based on Two Centers Large Sample
- ClinicalTrials.gov ID
- NCT06265493
- Acronym / sponsor ID
- PLAGH-AOC-L02
- Conditions
- Postoperative Infection, Geriatrics, Prediction
- Keywords
- postoperative infectious complications, elderly patients, retrospective study, prediction model, calculator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,230 participants (actual)
- Lead sponsor
- Weidong MiUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Feb 2024 (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.
The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections.
Detailed description
Background:
Postoperative infectious complications (PICs) are related to increased morbidity, mortality, and costs, especially in elderly patients. However, published prediction models of PICs are rarely based on elderly patients.
Objective:
The study wanted to identify practical and valuable variables that could be used to predict postoperative infections and establish a convenient scoring system for clinicians to assess the risk of such conditions in elderly patients.
Methods： Data from 2 population-based cohorts of elderly patients undergoing non-cardiac and non-neurology surgery were used to derive and validate multivariable logistic regression models. The risk prediction models were derived from 37230 patients hospitalized in the First Medical Center of the Chinese PLA General Hospital (January 2012 - August 2018). The risk prediction models were externally validated with data from a cohort of 10252 patients hospitalized in Henan Provincial People's Hospital (November 2014 to May 2022).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| derivation cohort | – | –29785 in the derivation cohort |
| internal validation cohort | – | –7445 in the internal validation cohort |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A total of 37230 participants were included in the derivation and internal validation cohorts (29785 in the derivation cohort and 7445 in the internal validation cohort).
Key inclusion criteria (2 listed)
- age ≥ 65 years and
- patients undergoing surgery with anesthesia.
Key exclusion criteria (3 listed)
- patients undergoing neurosurgery or cardiac surgery,
- preoperative infectious diseases, and
- patients with ≥50% of data missing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Infectious Complications Calculator for Elderly Patients
Time frame: January 2012 - August 2018
A Derivation and External Validation of Prediction Models based on two centers large sample
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 24 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Weidong Mi, Ph.D. study chair
Depatment of Anesthesiology, The First Medical Center Affiliation: 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 Infection and Geriatrics, run by Weidong Mi 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 3 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 24 Sep 2024. 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 Infectious Complications Calculator for Elderly Patients (time frame: January 2012 - August 2018). 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 24 Sep 2024.