SepsisNCT04904289
Early Recognition and Dynamic Risk Warning System of Multiple Organ Dysfunction Syndrome Caused by Sepsis
An observational study of Sepsis and MODS, run by Sun Yat-sen University at 18 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- All intervention of real world
- How many people
- 60,000 participants
- Where
- 18 sitesChina
- Study dates
- 21 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sepsis
Who may be able to join
- Patients diagnosed with sepsis3.0
Who cannot join
- Patients' data missing is greater than 20%
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites, 18 recruiting
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Zhou Feihu, M. D, zhoufh301@126.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Long Yun, M. D, 010-69152303, Ly_icu@aliyun.com
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Duan Meili, beauty9659@hotmail.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Jin Xiaodong, M. D, 028-85422508, zh_jxd@163.com
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
He Zhijie, M. D, 020-81332339, Hezhijie2004@126.com
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Li Yimin, M. D, 020-83062905, dryiminli@vip.163.com
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wu Jianfeng, M.D, 020-87755766 ext. 8454, wujianf@mail.sysu.edu.cn
Guan Xiangdong, M.D, 020-87755766 ext. 8456, guanxd@mail.sysu.edu.cn
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Cui Wei, M. D, 0571-87783632, iamcuiwei@aliyun.com
- Not yet recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310000
Yan Jing, M. D, 0571-87987373, zjicu@vip.163.com
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Sun Renhuang, M. D, 0571-85893283, Jqin168@hotmail.com
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250014
Wang Chunting, M. D, wcteicu@126.com
- Not yet recruiting
Nanjing General Hospital of Nanjing Military Commend
Nanjing, Jiangsu, 210000
Li Weiqin, M. D, 025-80861658, liweiqindr@vip.163.com
- Not yet recruiting
Qingyuan People's Hospital
Qingyuan, Guangdong
Lin Qinhan, linqinhanicu@163.com
- Not yet recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200000
Chen Erzhen, M. D, 021-4370045 ext. 665896, chenerzhen@hotmail.com
- Not yet recruiting
Shanghai Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Zhu Duming, M. D, 021-64041990 ext. 2724, duming_zhu@163.com
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Zhang Weixing, zhangwx@hotmail.com
- Not yet recruiting
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Shang You, shang_you@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
Wang Zheng, wangzheng0923@126.com
About this study
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.
Read more
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.
- Being tested
- All intervention of real world
- Keywords
- Sepsis, MODS, Big data, Artificial intelligence
- Medical subject headings
- Sepsis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All intervention of real worldOther
We analyzed all data we can obtain from our databases
| Study group | Role | What they receive |
|---|---|---|
| Sepsis with MODS | Patients with sepsis occurred MODS. Receives: Other: All intervention of real world | |
| Sepsis without MODS | Patients with sepsis did not occur MODS. Receives: Other: All intervention of real world |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the MODS recognized system
Measured: 90 days
Specificity of the MODS recognized system
Measured: 90 days
The AUC of the MODS recognized system ROC
Measured: 90 days
Secondary outcomes (2)
The Incidence rate of MODS in sepsis patients
The Incidence rate of MODS in Chinese sepsis patients
Measured: 90 days
The mortality of MODS in sepsis patients
The mortality of MODS in Chinese sepsis patients
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start21 Apr 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Jianfeng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904289
- Sponsor's protocol ID
- Early recognized of MODS
- Status last verified
- Sep 2022
- First submitted
- 23 May 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31804299Singer 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.
PubMed 26903338Stanski 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.
PubMed 31511662Liu 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.
PubMed 31039813
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recognition and Dynamic Risk Warning System of Multiple Organ Dysfunction Syndrome Caused by Sepsis
- ClinicalTrials.gov ID
- NCT04904289
- Acronym / sponsor ID
- Early recognized of MODS
- Keywords
- Sepsis, MODS, Big data, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis with MODS | – | Other: All intervention of real worldPatients with sepsis occurred MODS. |
| Sepsis without MODS | – | Other: All intervention of real worldPatients with sepsis did not occur MODS. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis
Key inclusion criteria (1 listed)
- Patients diagnosed with sepsis3.0
Key exclusion criteria (1 listed)
- Patients' data missing is greater than 20%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All intervention of real worldWe analyzed all data we can obtain from our databases | Other | Sepsis with MODS, Sepsis without MODS |
Primary outcome
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
2 secondary outcomes
The Incidence rate of MODS in sepsis patients
Time frame: 90 days
The mortality of MODS in sepsis patients
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Background: PubMed 31804299Xie 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.
- Background: PubMed 26903338Singer 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.
- Background: PubMed 31511662Stanski 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.
- Background: PubMed 31039813Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and MODS, run by Sun Yat-sen University at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangdong Guan, Dr (020-87755766 ext. 8454, guanxd@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the MODS recognized system (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904289, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.