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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From ICU admission to 7 days after admission (for outcome assessment). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
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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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D055371 | Acute Lung Injury |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |