Developing a Risk Assessment System of Multidrug-resistant Organisms Infection

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688216
• Other study ID #: 2020-408
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 917
• Est. completion date: December 30, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections

Intervention

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, APACHE? 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

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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