- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265493
Postoperative Infectious Complications Calculator for Elderly Patients
Postoperative Infectious Complications Calculator for Elderly Patients--A Derivation and External Validation of Prediction Models Based on Two Centers Large Sample
Study Overview
Status
Conditions
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 2004 - December 2019). 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100853
- Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age ≥ 65 years and
- patients undergoing surgery with anesthesia.
Exclusion Criteria:
- patients undergoing neurosurgery or cardiac surgery,
- preoperative infectious diseases, and
- patients with ≥50% of data missing.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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derivation cohort
29785 in the derivation cohort
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internal validation cohort
7445 in the internal validation cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Infectious Complications Calculator for Elderly Patients
Time Frame: January 2004 - December 2019
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A Derivation and External Validation of Prediction Models based on two centers large sample
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January 2004 - December 2019
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Weidong Mi, Ph.D., Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH-AOC-L02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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