Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB

NCT07583290 | Active Not Recruiting

• 1 other identifier: 2025-10-AURORA
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiopulmonary Bypass; Systemic Inflammatory Response Syndrome; Multiple Organ Dysfunction Syndrome; Postoperative Complications; Cardiac Surgical Procedures

Keywords

Ulinastatin; Cardiac Surgery; Cardiopulmonary Bypass; Machine Learning; Precision Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence rate of MODS

  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.

Interventions

ulinastatin DRUG

The patient used ulinastatin during the operation and while hospitalized in the ICU, and received mechanical ventilation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Center for Cardiac Surgery and Critical Care

Beijing, China

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Multiple Organ Failure; Postoperative Complications

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: May 13, 2026
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

CN (1)