Developing a Risk Assessment System of Multidrug-resistant Organisms Infection

NCT04688216 | Completed

• 1 other identifier: 2020-408
• Study Type: observational
• Target: 917
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019.
2. 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. 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. 4.Predict the patient's infection risk level according to the best risk assessment system and develop a low-to-high intervention plan.

Conditions

Bacterial Infections

Keywords

risk assessment system; multidrug-resistant organisms; ICU

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MDRO

Other: risk factors of infection with multidrug-resistant organisms

Non-MDRO

Other: risk factors of infection with multidrug-resistant organisms

Interventions

risk factors of infection with multidrug-resistant organisms OTHER

1. 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. 2. 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. 3. 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

MDRO; Non-MDRO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 29, 2020
• Study Start: January 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: December 30, 2022
• Last Updated: May 26, 2023

Record last verified: 2022-12

Locations

CN (1)