Developing a Risk Assessment System of Multidrug-resistant Organisms Infection

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04688216
Collaborator
(none)
917
1
35.9
25.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: risk factors of infection with multidrug-resistant organisms

Study Design

Study Type:
Observational
Anticipated Enrollment :
917 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Developing the Best Risk Assessment System of Multidrug-resistant Organisms Infection in Critically Ill Patients Based on Big Data Analysis Technology
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Whether multidrug-resistant organisms infection [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ①Length of stay in ICU is more than 48h; ② no less than 18 years old.
Exclusion Criteria:
  • ①Patients with MDRO infection at the time of admission; ②Inpatient time in ICU <48h; ③Lack of case data; ④ MDRO colonized patients.

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310009

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04688216
Other Study ID Numbers:
  • 2020-408
First Posted:
Dec 29, 2020
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2020