SepsisNCT07317817
Research on Risk Assessment and Early Warning Models for Adverse Clinical Outcomes in Critically Ill Patients
An observational study of Sepsis and ARDS (Acute Respiratory Distress Syndrome), run by Chongqing Medical University at 1 site in China.
Trial summary
This is a medical research study that uses information from past patient hospital records. It focuses on three serious conditions that often affect critically ill patients: sepsis (a life-threatening body-wide infection), ARDS (a severe lung injury that makes breathing very difficult), and acute kidney injury (sudden… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, ARDS (Acute Respiratory Distress Syndrome), AKI - Acute Kidney Injury
- How many people
- 55,940 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 31 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective cohort of critically ill adult patients admitted to the intensive care unit (ICU). The study population will be derived from de-identified electronic health records.
Who may be able to join
- Adult patients (age ≥ 18 years).
- Admitted to the ICU with a length of stay ≥ 24 hours.
- Availability of key clinical variables within the first 24 hours of ICU admission (e.g., vital signs, laboratory results, admission diagnosis).
Who cannot join
- Patients with incomplete or missing key data for model variables (e.g., missing baseline creatinine, or missing Sequential Organ Failure Assessment (SOFA) score components).
- Patients admitted for palliative care or comfort measures only upon ICU admission.
- Readmissions during the same hospitalization (only the first ICU admission will be included).
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
This is a medical research study that uses information from past patient hospital records. It focuses on three serious conditions that often affect critically ill patients: sepsis (a life-threatening body-wide infection), ARDS (a severe lung injury that makes breathing very difficult), and acute kidney injury (sudden loss of kidney function). The goal is to better understand which patients in the ICU are at highest risk of developing these conditions or getting worse. Researchers will look at de-identified information from medical records of patients treated in the ICU . The study will use computer analysis to find patterns in the data that may help doctors predict these risks earlier. No new treatments are being tested, and no patients will be contacted or recruited for this study. All data used is anonymous to protect patient privacy.
- Being tested
- No intervention (Observational study)
- Medical subject headings
- Sepsis, Acute Lung Injury, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (Observational study)Other
This is a non-interventional, observational study. The aim is to develop and validate a predictive model using existing clinical data. No medical interventions (such as drugs, devices, or procedures) are being administered, assigned, or compared as part of this research protocol. The "intervention" of interest is the application of the predictive model for risk assessment, which is an analytical procedure, not a patient-directed intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUROC) for predicting the composite outcome of Sepsis, ARDS, or Acute Kidney Injury
The discriminatory power of the machine learning model will be assessed by the AUROC. The value ranges from 0 to 1, with a higher value indicating better ability to distinguish between patients who will and will not experience the composite outcome.
Measured: From ICU admission to 7 days after admission (for outcome prediction)
Calibration of predicted risk, measured by the Brier Score
The accuracy of the model's predicted probabilities will be assessed using the Brier Score (range 0 to 1, lower scores indicate better calibration). A calibration plot will be presented to visualize the agreement between predicted and observed event rates.
Measured: From ICU admission to 7 days after admission (for outcome assessment).
Sensitivity (Recall) for the composite outcome at a pre-defined risk threshold
Performance metric calculated after applying a pre-defined probability cut-off to classify patients as high-risk or low-risk.
Measured: From ICU admission to 7 days after admission (for outcome assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Oct 2017
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55,940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yalin Dong, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317817
- Sponsor's protocol ID
- 2024167
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) underlying the results of this study cannot be made publicly available due to restrictions imposed by Chinese data protection laws and regulations, as well as the data use agreements with the source hospital(s). The data contain sensitive clinical information, and public sharing would compromise patient privacy and confidentiality. Aggregated data or analysis results will be made available in the published manuscript. Requests for specific analyses can be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Risk Assessment and Early Warning Models for Adverse Clinical Outcomes in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07317817
- Acronym / sponsor ID
- 2024167
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,940 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 5 Jan 2026 (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.
This is a medical research study that uses information from past patient hospital records. It focuses on three serious conditions that often affect critically ill patients: sepsis (a life-threatening body-wide infection), ARDS (a severe lung injury that makes breathing very difficult), and acute kidney injury (sudden loss of kidney function). The goal is to better understand which patients in the ICU are at highest risk of developing these conditions or getting worse. Researchers will look at de-identified information from medical records of patients treated in the ICU . The study will use computer analysis to find patterns in the data that may help doctors predict these risks earlier. No new treatments are being tested, and no patients will be contacted or recruited for this study. All data used is anonymous to protect patient privacy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective cohort of critically ill adult patients admitted to the intensive care unit (ICU). The study population will be derived from de-identified electronic health records.
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years).
- Admitted to the ICU with a length of stay ≥ 24 hours.
- Availability of key clinical variables within the first 24 hours of ICU admission (e.g., vital signs, laboratory results, admission diagnosis).
Key exclusion criteria (3 listed)
- Patients with incomplete or missing key data for model variables (e.g., missing baseline creatinine, or missing Sequential Organ Failure Assessment (SOFA) score components).
- Patients admitted for palliative care or comfort measures only upon ICU admission.
- Readmissions during the same hospitalization (only the first ICU admission will be included).
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 |
|---|---|---|
| No intervention (Observational study)This is a non-interventional, observational study. The aim is to develop and validate a predictive model using existing clinical data. No medical interventions (such as drugs, devices, or procedures) are being administered, assigned, or compared as part of this research protocol. The "intervention" of interest is the application of the predictive model for risk assessment, which is an analytical procedure, not a patient-directed intervention. | Other | – |
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUROC) for predicting the composite outcome of Sepsis, ARDS, or Acute Kidney Injury
Time frame: From ICU admission to 7 days after admission (for outcome prediction)
The discriminatory power of the machine learning model will be assessed by the AUROC. The value ranges from 0 to 1, with a higher value indicating better ability to distinguish between patients who will and will not experience the composite outcome.
Calibration of predicted risk, measured by the Brier Score
Time frame: From ICU admission to 7 days after admission (for outcome assessment).
The accuracy of the model's predicted probabilities will be assessed using the Brier Score (range 0 to 1, lower scores indicate better calibration). A calibration plot will be presented to visualize the agreement between predicted and observed event rates.
Sensitivity (Recall) for the composite outcome at a pre-defined risk threshold
Time frame: From ICU admission to 7 days after admission (for outcome assessment).
Performance metric calculated after applying a pre-defined probability cut-off to classify patients as high-risk or low-risk.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) underlying the results of this study cannot be made publicly available due to restrictions imposed by Chinese data protection laws and regulations, as well as the data use agreements with the source hospital(s). The data contain sensitive clinical information, and public sharing would compromise patient privacy and confidentiality. Aggregated data or analysis results will be made available in the published manuscript. Requests for specific analyses can be directed to the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis and ARDS (Acute Respiratory Distress Syndrome), run by Chongqing Medical University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (AUROC) for predicting the composite outcome of Sepsis, ARDS, or Acute Kidney Injury (time frame: From ICU admission to 7 days after admission (for outcome prediction)). 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?
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 5 Jan 2026.