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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana
- Center for Cardiac Surgery and Critical Care
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
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All-cause mortality
Periodo de tiempo: 30 days after the operation
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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.
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30 days after the operation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The incidence rate of MODS
Periodo de tiempo: 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.
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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.
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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.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-10-AURORA
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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