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Clinical Trials/NCT04904289
NCT04904289
Recruiting
Not Applicable

Early Recognition and Dynamic Risk Warning System of Multiple Organ Dysfunction Syndrome Caused by Sepsis

Sun Yat-sen University18 sites in 1 country60,000 target enrollmentApril 21, 2022
ConditionsSepsisMODS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Sun Yat-sen University
Enrollment
60000
Locations
18
Primary Endpoint
Sensitivity of the MODS recognized system
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Background Sepsis still the main challenge of ICU patients, because of its high morbidity and mortality. The proportion of sepsis, severe sepsis, and septic shock in china were 3.10%, 43.6%, and 53.3% with a 2.78%, 17.69%, and 51.94%, of 90-day mortality, respectively.

Besides, according to the latest definition of sepsis- "a life-threatening organ dysfunction caused by a dysregulated host response to infection. ", it is a disease with intrinsic heterogeneity. Sepsis as a syndrome with such great heterogeneity, there will be significant differences in the severity of sepsis. As a result, there will be significant differences in the treatment and monitoring intensity required by patients with severe sepsis and mild sepsis. No matter from the economic perspective or from the risk of treatment, a proper level of treatment will be the best chose of patient. However, the evaluation of the sepsis severity was not satisfied. Such of SOFA, the AUC of predict patients' mortality was only 69%. Weather these patients occurred multiple organ dysfunction syndrome (MODS) may had totally different outcome and needed totally different treatment. All these treatments need early interference, in order to achieve a good prognosis. Hence, early recognition of MODS caused by sepsis became an imperious demand.

Study design On the base of regional critical medicine clinical information platform, a multi-center, sepsis big data platform (including clinical information database and biological sample database) and a long-term follow-up database will be established. Thereafter, an early identification, risk classification and dynamic early warning system of sepsis induced MODS will be established. This system was based on the real-time dynamic vital signs and clinical information, combined with biomarker and multi-omics information. And this system was evaluated sepsis patients via artificial intelligence, machine learning, bioinformatics analysis techniques.

Finally, optimize the early diagnosis of sepsis induced MODS, standardized the treatment strategy, reduce the morbidity and mortality of MODS through this system.

Registry
clinicaltrials.gov
Start Date
April 21, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Wu Jianfeng

prof

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with sepsis3.0

Exclusion Criteria

  • Patients' data missing is greater than 20%

Outcomes

Primary Outcomes

Sensitivity of the MODS recognized system

Time Frame: 90 days

Specificity of the MODS recognized system

Time Frame: 90 days

The AUC of the MODS recognized system ROC

Time Frame: 90 days

Secondary Outcomes

  • The mortality of MODS in sepsis patients(90 days)
  • The Incidence rate of MODS in sepsis patients(90 days)

Study Sites (18)

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