Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB (AURORA)

Development and Validation of an AI-Based Tool for Identifying Responders and Stratifying Risks in Ulinastatin Treatment in Cardiac Surgery: A Multicenter Real-world Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Systemic Inflammatory Response Syndrome; Postoperative Complications; Cardiopulmonary Bypass; Cardiac Surgical Procedures; Multiple Organ Dysfunction Syndrome
• Intervention / Treatment: Drug: ulinastatin

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Center for Cardiac Surgery and Critical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Patients underwent extracorporeal circulation heart surgery, including coronary artery bypass grafting, valve repair or replacement surgery, congenital heart defect repair surgery, and major vascular and aortic disease surgeries;
• Patients received standard treatment (such as anticoagulation, circulatory support), with or without ulinastatin.

Exclusion Criteria:

• Patients who had undergone cardiopulmonary bypass surgery multiple times;
• Patients with incomplete clinical records, lacking key information such as patient ID, age, gender and disease diagnosis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Cardiopulmonary Bypass; Precision Medicine; Machine Learning; Ulinastatin
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Multiple Organ Failure; Postoperative Complications; Systemic Inflammatory Response Syndrome; urinastatin
• Other Study ID Numbers: 2025-10-AURORA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No