Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB

N/AActive Not RecruitingNCT07583290

Beijing Anzhen Hospital10,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

10,000

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.