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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904289
• Other study ID #: Early recognized of MODS
• Status: Recruiting
• Start date: April 21, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Sun Yat-sen University
• Contact: Xiangdong Guan, Dr
• Phone: 020-87755766
• Email: guanxd[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60000
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with sepsis3.0

Exclusion Criteria:

• Patients' data missing is greater than 20%

Related Conditions & MeSH terms

• MODS
• Multiple Organ Failure
• Sepsis
• Toxemia

Intervention

Other:
• All intervention of real world
We analyzed all data we can obtain from our databases

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	Nanjing General Hospital of Nanjing Military Commend	Nanjing	Jiangsu
China	Qingyuan People's Hospital	Qingyuan	Guangdong
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	Shanghai Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

Liu Z, Meng Z, Li Y, Zhao J, Wu S, Gou S, Wu H. Prognostic accuracy of the serum lactate level, the SOFA score and the qSOFA score for mortality among adults with Sepsis. Scand J Trauma Resusc Emerg Med. 2019 Apr 30;27(1):51. doi: 10.1186/s13049-019-0609-3. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Stanski NL, Wong HR. Prognostic and predictive enrichment in sepsis. Nat Rev Nephrol. 2020 Jan;16(1):20-31. doi: 10.1038/s41581-019-0199-3. Epub 2019 Sep 11. Review. — View Citation

Xie J, Wang H, Kang Y, Zhou L, Liu Z, Qin B, Ma X, Cao X, Chen D, Lu W, Yao C, Yu K, Yao X, Shang H, Qiu H, Yang Y; CHinese Epidemiological Study of Sepsis (CHESS) Study Investigators. The Epidemiology of Sepsis in Chinese ICUs: A National Cross-Sectional Survey. Crit Care Med. 2020 Mar;48(3):e209-e218. doi: 10.1097/CCM.0000000000004155. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the MODS recognized system		90 days
Primary	Specificity of the MODS recognized system		90 days
Primary	The AUC of the MODS recognized system ROC		90 days
Secondary	The Incidence rate of MODS in sepsis patients	The Incidence rate of MODS in Chinese sepsis patients	90 days
Secondary	The mortality of MODS in sepsis patients	The mortality of MODS in Chinese sepsis patients	90 days