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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06265493
Other study ID # PLAGH-AOC-L02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date September 30, 2023

Study information

Verified date March 2024
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Higher-score patients were more likely to experience postoperative infections.


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).


Recruitment information / eligibility

Status Completed
Enrollment 37230
Est. completion date September 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. age = 65 years and 2. patients undergoing surgery with anesthesia. Exclusion Criteria: 1. patients undergoing neurosurgery or cardiac surgery, 2. preoperative infectious diseases, and 3. patients with =50% of data missing.

Study Design


Locations

Country Name City State
China Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Weidong Mi

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Infectious Complications Calculator for Elderly Patients A Derivation and External Validation of Prediction Models based on two centers large sample January 2004 - December 2019
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