Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Surgical Procedures Cardiopulmonary Bypass Inflammation Multiple Organ Dysfunction Syndrome Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Cardiac Surgery and Critical Care

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ulinastatin

Drug

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

Primary outcomes

All-cause mortality

Time frame: 30 days after the operation

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.

Secondary outcomes

The incidence rate of MODS

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.

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.

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Acronym: AURORA

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2027
First posted: May 13, 2026
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed