MoralityNCT03883061
Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis
An observational study of Morality and Risk Factor, Sepsis, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
The purpose of this study was to investigate the risk factors for mortality of sepsis and to create mathematical models to predict the survival rate based on electronic health records that extracted from hospital information system. More than 1000 records should be collected and used to data analysis. Read more about this study
- Who is it for?
- Ages 14 to 99 years
- Conditions the study is for
- Morality, Risk Factor, Sepsis, Predictive Model
- What is being tested?
- regular medical treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2021
- How long will I take part?
- 1 Month
- 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 14 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with sepsis in emergence department of hospitals
Who may be able to join
- all records with sepsis in emergence department of hospitals
Who cannot join
- subjects with major missing data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zihui Tang
Shanghai
Zihui Tang, Dr, 15821993541 ext. 021, albert.tang@163.com
Yu Lu, Dr
About this study
Official title: Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis Based on Real World Data in China
The purpose of this study was to investigate the risk factors for mortality of sepsis and to create mathematical models to predict the survival rate based on electronic health records that extracted from hospital information system. More than 1000 records should be collected and used to data analysis. Univariate and multivariable logistic regression model were applied to risk factors analysis for the outcome, and machine learn algorithms were employed to generate predictive models for the outcome.
- Conditions
- Morality, Risk Factor, Sepsis, Predictive Model
- Being tested
- regular medical treatment
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular medical treatmentOther
regular medical treatment
| Study group | Role | What they receive |
|---|---|---|
| mortality of sepsis | the study sample would be extracted from electronic health records in emergence departments. risk factor analysis and mathematical modeling would be performed to evaluate the significant and independent risk factors and predictive models. Receives: Other: regular medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality of sepsis
mortality of sepsis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jan 2017
- Primary completion1 Mar 2019
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoralityStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of University of South China, Department of Integrative Medicine, Huashan Hospital of Fudan University, Shanghai, China, Department of Biomedical Informatics and Statistics, Insitute of Integrative Medicine, Fudan University, Shanghai, China, Department of emergence, Hunan people's hospital, Changhai, Hunan, China, Affiliated Hospital of Jining Medical University, Department of emergence, Huaihua people's hospital, Huaihua, Hunan, China
- Responsible party
- Principal investigator, Zihui Tang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883061
- Sponsor's protocol ID
- 20190319
- Status last verified
- Jan 2021
- First submitted
- 19 Mar 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu Y, Tang ZH, Zeng F, Li Y, Zhou L. The association and predictive value analysis of metabolic syndrome combined with resting heart rate on cardiovascular autonomic neuropathy in the general Chinese population. Diabetol Metab Syndr. 2013 Nov 17;5(1):73. doi: 10.1186/1758-5996-5-73.
PubMed 24238358
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis Based on Real World Data in China
- ClinicalTrials.gov ID
- NCT03883061
- Acronym / sponsor ID
- 20190319
- Conditions
- Morality, Risk Factor, Sepsis, Predictive Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of University of South China, Department of Integrative Medicine, Huashan Hospital of Fudan University, Shanghai, China, Department of Biomedical Informatics and Statistics, Insitute of Integrative Medicine, Fudan University, Shanghai, China, Department of emergence, Hunan people's hospital, Changhai, Hunan, China, Affiliated Hospital of Jining Medical University, Department of emergence, Huaihua people's hospital, Huaihua, Hunan, China
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Mar 2019 (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.
The purpose of this study was to investigate the risk factors for mortality of sepsis and to create mathematical models to predict the survival rate based on electronic health records that extracted from hospital information system. More than 1000 records should be collected and used to data analysis. Univariate and multivariable logistic regression model were applied to risk factors analysis for the outcome, and machine learn algorithms were employed to generate predictive models for the outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mortality of sepsis | – | Other: regular medical treatmentthe study sample would be extracted from electronic health records in emergence departments. risk factor analysis and mathematical modeling would be performed to evaluate the significant and independent risk factors and predictive models. |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with sepsis in emergence department of hospitals
Key inclusion criteria (1 listed)
- all records with sepsis in emergence department of hospitals
Key exclusion criteria (1 listed)
- subjects with major missing data
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 |
|---|---|---|
| regular medical treatmentregular medical treatment | Other | mortality of sepsis |
Primary outcome
mortality of sepsis
Time frame: 4 weeks
mortality of sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 24238358Lu Y, Tang ZH, Zeng F, Li Y, Zhou L. The association and predictive value analysis of metabolic syndrome combined with resting heart rate on cardiovascular autonomic neuropathy in the general Chinese population. Diabetol Metab Syndr. 2013 Nov 17;5(1):73. doi: 10.1186/1758-5996-5-73.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morality and Risk Factor, Sepsis, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality of sepsis (time frame: 4 weeks). 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 NCT03883061, which also lists 1 linked publication.
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 Jan 2021.