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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04904289

Collaborator

(none)

60,000

Enrollment

Locations

Anticipated Duration (Months)

3333.3

Patients Per Site

128.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis MODS	Other: All intervention of real world

Study Design

Study Type:

Observational

Anticipated Enrollment :

60000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 31, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Sensitivity of the MODS recognized system [90 days]
Specificity of the MODS recognized system [90 days]
The AUC of the MODS recognized system ROC [90 days]

Secondary Outcome Measures

The Incidence rate of MODS in sepsis patients [90 days]
The Incidence rate of MODS in Chinese sepsis patients
The mortality of MODS in sepsis patients [90 days]
The mortality of MODS in Chinese sepsis patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with sepsis3.0

Exclusion Criteria:

Patients' data missing is greater than 20%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100000
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100000
3	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	510000
4	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510000
5	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510080
6	Qingyuan People's Hospital	Qingyuan	Guangdong	China
7	Peking University Shenzhen Hospital	Shenzhen	Guangdong	China
8	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China
9	Nanjing General Hospital of Nanjing Military Commend	Nanjing	Jiangsu	China	210000
10	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi	China
11	Shandong Provincial Hospital	Jinan	Shandong	China	250014
12	Shanghai Ruijin Hospital	Shanghai	Shanghai	China	200000
13	Shanghai Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200000
14	West China Hospital, Sichuan University	Chengdu	Sichuan	China	610000
15	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000
16	Zhejiang Hospital	Hangzhou	Zhejiang	China	310000
17	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310000
18	Beijing Friendship Hospital, Capital Medical University	Beijing		China