An observational study in Cardiac Surgical Procedures, Cardiopulmonary Bypass and Systemic Inflammatory Response Syndrome, sponsored by Beijing Anzhen Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Beijing Anzhen Hospital · Observational
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.
195 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 134 across 94 observational studies indexed under Systemic Inflammatory Response Syndrome.
Browse Systemic Inflammatory Response Syndrome studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.
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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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Exclusion Criteria:
The patient used ulinastatin during the operation and while hospitalized in the ICU, and received mechanical ventilation.
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.
Time frame: 30 days after the operation
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.
Time frame: 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.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Dec 2024, 83 months.
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Systemic Inflammatory Response Syndrome →