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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04913181
Other study ID # SHZJU-ICU2020-202
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date June 1, 2023

Study information

Verified date May 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact ?? ?
Phone 13685753994
Email deter_leung@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The development of sepsis prediction model in line with Chinese population, and extended to clinical, assist clinicians for early identification, early intervention, has a good application prospect. This study is a prospective observational study, mainly to evaluate the accuracy of the previously established sepsis prediction model. The occurrence of sepsis was determined by doctors' daily clinical judgment, and the results of the sepsis prediction model were matched and corrected to improve the clinical accuracy and applicability of the sepsis prediction model.


Description:

The sepsis prediction model adopted in this study has been completed in the preliminary preparation, which was constructed on 7,000 patients since the establishment of comprehensive ICU, and the sepsis 3.0 diagnostic standard was adopted.The sepsis prediction model was built using Python platform and XGBoost algorithm, which was used to predict the incidence of sepsis in ICU patients within 24 hours. The overall accuracy was 82%, and the area under the Auroc curve was 0.854. Patients who met the inclusion and exclusion criteria were given a daily prediction of sepsis model, and a quantitative checklist was formed based on the test results.There are two kinds of forecast outcomes: low risk and high risk.Quantitative checklists are available to attending physicians to improve diagnostic efficiency.The results were kept confidential to the clinician. All patients were diagnosed with sepsis by two senior attending physicians at a fixed time. The diagnosis consisted of two types: yes and no.If two attending physicians have different opinions, the third attending physician will be included for correction diagnosis, and the presence of sepsis will be determined in a 2:1 manner.The attending physicians are independent of each other. When the diagnosis results of the attending physician are input into the system, the prediction results of yesterday's sepsis prediction model are compared and calculated to determine the accuracy of the prediction model


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date June 1, 2023
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years to 100 Years
Eligibility Inclusion Criteria: All patients with acute critical illness who are eligible for admission to ICU during the study period Exclusion Criteria: 1. Patients under the age of 16; 2. Pregnant and parturient women; 3. Patients who planned to be admitted to the department for surgery and transferred the next day after evaluation; 4. Patients admitted to the department and diagnosed with sepsis; 5. Patients with ICU stay less than 24 hours;

Study Design


Intervention

Diagnostic Test:
Artificial intelligence sepsis prediction model
The main purpose of this paper is to evaluate the accuracy of the sepsis prediction model established in the early stage. The occurrence of sepsis is determined by the daily clinical judgment of doctors, and the results of sepsis prediction model are matched and corrected.

Locations

Country Name City State
n/a

Sponsors (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of model diagnosis Evaluation of the accuracy of prediction model in clinical application 2 years
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