Developing a Risk Assessment System of Multidrug-resistant Organisms Infection

Developing the Best Risk Assessment System of Multidrug-resistant Organisms Infection in Critically Ill Patients Based on Big Data Analysis Technology

1. A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019.
2. Non-MDRO patients were selected by random sampling in a ratio of 1:1 to the final MDRO group during the same period , and select the risk factors of infection with multi-drug resistant bacteria by comparing the two groups.
3. Randomly select 30% of the sample size as the validation set, and the remaining 70% for the training set to establish a model. Using multi-factor Logistic regression, decision tree classification, artificial neural network, support vector machine, Bayesian network Method to establish risk assessment system for multidrug-resistant organisms infection respectively.Using validation set data to calculate the area under the ROC curve (AUC) and sensitivity, specificity of models and comparing the prediction accuracy of several models. Finally, choose a more suitable risk assessment system for multidrug-resistant organisms infection.
4. Predict the patient's infection risk level according to the best risk assessment system and develop a low-to-high intervention plan.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Other: risk factors of infection with multidrug-resistant organisms

• Study Type: Observational
• Enrollment (Actual): 917

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

①Length of stay in ICU is more than 48h; ② no less than 18 years old.

Description

Inclusion Criteria：

• Duration of ICU admission ≥ 48h
• no less than 18 years old

Exclusion Criteria:

• Patients with MDRO infection at the time of admission
• Lack of case data
• MDRO colonized patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MDRO	Other: risk factors of infection with multidrug-resistant organisms; General information: age, gender, length of stay in ICU, method of admission, tubes taken at the time of admission, APACHEⅡ score, surgery, laboratory tests (PCT, CRP, WBC), pressure sores, etc.; Iatrogenic factors: days of using ventilator, days of using antibacterial drugs, types of antibacterial drugs, use of glucocorticoids, use of immunosuppressants, days of central venous intubation, days of indwelling catheters, days of arterial catheterization, and other indwelling catheters.; The patient's own related factors: diagnosis, whether complicated with hypertension or diabetes; whether exist malignant tumor, primary lung infection, hypoproteinemia; whether antibiotic treatment before admission; fever and fever days, whether diarrhea occurs
Non-MDRO	Other: risk factors of infection with multidrug-resistant organisms; General information: age, gender, length of stay in ICU, method of admission, tubes taken at the time of admission, APACHEⅡ score, surgery, laboratory tests (PCT, CRP, WBC), pressure sores, etc.; Iatrogenic factors: days of using ventilator, days of using antibacterial drugs, types of antibacterial drugs, use of glucocorticoids, use of immunosuppressants, days of central venous intubation, days of indwelling catheters, days of arterial catheterization, and other indwelling catheters.; The patient's own related factors: diagnosis, whether complicated with hypertension or diabetes; whether exist malignant tumor, primary lung infection, hypoproteinemia; whether antibiotic treatment before admission; fever and fever days, whether diarrhea occurs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
multidrug-resistant organisms infection	Ratio of the number of multi-drug resistant bacterial infections to the total number of patients	From date of ICU admissions until the date of ICU discharge or date of diagnosis of multidrug-resistant organisms infection , whichever came first, assessed up to 24 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ICU; risk assessment system; multidrug-resistant organisms
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: 2020-408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No