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This is a multicenter, retrospective, real-world observational study aimed at developing and validating an artificial intelligence-based tool for identifying ulinastatin treatment responders and risk stratification in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).
Ulinastatin, a glycoprotein extracted from human urine, has shown potential benefits in reducing postoperative complications and inflammatory responses in cardiac surgery. However, evidence supporting its efficacy and optimal application in specific patient populations remains insufficient.
This study will collect clinical data from approximately 4 tertiary cardiac centers in China, including patients who underwent cardiac surgery with CPB. Using machine learning algorithms (such as weighted K-modes clustering and XGBoost), the study aims to: (1) construct a multicenter real-world database for cardiac surgery; (2) identify clinical characteristics associated with ulinastatin treatment response; (3) develop and validate an AI-based risk stratification tool to assist clinical decision-making. This study may provide evidence-based guidance for personalized perioperative anti-inflammatory treatment in cardiac surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ulinastatin | Drug | The patient used ulinastatin during the operation and while hospitalized in the ICU, and received mechanical ventilation. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality occurring during the hospitalization period following cardiac surgery with cardiopulmonary bypass. Mortality is defined as death from any cause that occurs from the time of surgery until hospital discharge, including deaths related to cardiovascular events, multiple organ dysfunction syndrome (MODS), infection, bleeding, or other complications. | 30 days after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of MODS | The number of new MODS cases occurring in the targeted patients during research time period, divided by the total number of individuals at risk over the same period. | From the date of hospitalization until the date of hospital discharge or 30 days after the operation, whichever occurs first, assessed up to 30 days postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent cardiac surgery with cardiopulmonary bypass at 4 tertiary cardiac centers in China, including coronary artery bypass grafting, valve surgery, congenital heart defect repair, and major vascular surgery. Patients are categorized based on perioperative ulinastatin use (ulinastatin group vs. control group). Data collected from electronic medical records.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cardiac Surgery and Critical Care | Beijing | China |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D009102 | Multiple Organ Failure |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| C028665 | urinastatin |
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