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

September 2, 2022 updated by: Wu Jianfeng, Sun Yat-sen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guan Xiangdong, M.D
        • Sub-Investigator:
          • Wu Jianfeng, M.D
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
      • Qingyuan, Guangdong, China
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Nanjing General Hospital of Nanjing Military Commend
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi 'An Jiaotong University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250014
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Shanghai Ruijin Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Shanghai Zhongshan Hospital, Fudan University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Zhejiang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with sepsis

Description

Inclusion Criteria:

  • Patients diagnosed with sepsis3.0

Exclusion Criteria:

  • Patients' data missing is greater than 20%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sepsis with MODS
Patients with sepsis occurred MODS.
Other: All intervention of real world
We analyzed all data we can obtain from our databases
Sepsis without MODS
Patients with sepsis did not occur MODS.
Other: All intervention of real world
We analyzed all data we can obtain from our databases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of the MODS recognized system
Time Frame: 90 days
90 days
Specificity of the MODS recognized system
Time Frame: 90 days
90 days
The AUC of the MODS recognized system ROC
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence rate of MODS in sepsis patients
Time Frame: 90 days
The Incidence rate of MODS in Chinese sepsis patients
90 days
The mortality of MODS in sepsis patients
Time Frame: 90 days
The mortality of MODS in Chinese sepsis patients
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 23, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Early recognized of MODS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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