- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07803328
Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury (PROVE-AKI)
1 de septiembre de 2026 actualizado por: Universität Münster
The goal of this prospective observational study is to find out whether the protein vascular endothelial growth factor (VEGF) measured in blood and urine can predict which patients will develop acute kidney injury (AKI) after heart-type surgery that uses a heart-lung machine (cardiopulmonary bypass).
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
Cardiac surgery-associated acute kidney injury (CSA-AKI) remains a common and serious complication affecting 20-30% of patients undergoing cardiac surgery, with significant implications for short- and long-term morbidity and mortality.
The pathophysiology of CSA-AKI is multifactorial and incompletely understood.
It involves hypoperfusion, ischemia-reperfusion injury, inflammation, and oxidative stress.
Emerging evidence suggests that vascular endothelial dysfunction and microvascular injury play central roles in the development and progression of CSA-AKI.
Vascular endothelial growth factor (VEGF) is a key regulator of endothelial cell survival, vascular permeability, inflammation, and angiogenesis.
VEGF appears to play a critical role in maintaining renal microvascular homeostasis.
While renal VEGF expression in vitro is induced by hypoxia, its renal expression and protein plasma levels have been shown to drop significantly following ischemia-reperfusion injury in a mouse model.
These observations have been supported by an observational study that found an approximately 2-fold decrease in plasma concentrations of VEGF by 6 hours in patients that had underwent cardiac surgery with cardiopulmonary bypass (CPB).
Conversely, higher early postoperative VEGF plasma concentrations have been independently associated with significantly reduced risk of AKI, shorter AKI duration and improved survival, suggesting a protective role for VEGF in the acute phase of CSA-AKI.
However, while VEGF appears to be nephroprotective in the acute phase after cardiac surgery, it potentially contributes to chronic kidney disease (CKD) progression due to fibrosis and is associated with higher risk for progression to end stage kidney disease in patients with diabetic nephropathy.
Despite these insights, the reliance of the only clinical study by Mansour et al. on plasma VEGF measurements may limit the precision with which renal VEGF dynamics can be characterized.
Plasma VEGF reflects contributions from multiple non-renal sources, including platelets, leukocytes, vascular endothelium, and other tissues, all of which are substantially perturbed in the context of cardiac surgery.
The resulting hemodilution, platelet activation and systemic inflammatory response inherent to extracorporeal circulation represent important confounders of circulating VEGF levels that are unrelated to renal pathophysiology.
Consequently, the observed 2-fold decrease in plasma VEGF following cardiac surgery³ likely represents an attenuated and partially masked signal of what preclinical data suggest to be a far more pronounced local renal VEGF suppression.
In contrast, urinary VEGF may provide a more specific representation of intrarenal VEGF (predominantly produced by glomerular podocytes) that is less susceptible to systemic confounders.
Given the magnitude of renal VEGF suppression documented in the IRI model, urinary VEGF concentrations would be expected to demonstrate a substantially larger and more consistent signal in patients developing CSA-AKI compared to plasma-based measurements.
The precise role of VEGF in the pathophysiology of CSA-AKI thus remains unclear.
To date, urinary VEGF has not been systematically evaluated as a biomarker in the context of CSA-AKI, and direct comparative data with plasma VEGF in this setting are lacking.
The temporal changes of VEGF expression, its relationship to specific injury mechanisms such as ischemia-reperfusion injury, oxidative stress, and inflammation and its potential utility as a predictive biomarker in the plasma/urine or therapeutic target require further investigation.
The objective of this study is to comprehensively evaluate the role of VEGF in CSA-AKI by examining its urine and plasma concentration over time in relation to clinical outcomes.
First, we aim to determine whether perioperative VEGF levels can serve as a predictive biomarker for CSA- AKI development, severity, and duration.
Second, we aim to elucidate the mechanistic pathways through which VEGF influences AKI and recovery in the cardiac surgery setting.
Understanding the significance of VEGF in CSA-AKI may identify novel opportunities for risk stratification and possibly therapeutic interventions to improve kidney outcomes in this high-risk patient population.
Tipo de estudio
De observación
Inscripción (Estimado)
220
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Alexander Zarbock, MD
- Número de teléfono: +49251-8347255
- Correo electrónico: zarbock@uni-muenster.de
Copia de seguridad de contactos de estudio
- Nombre: Moritz Mertes, MD
- Número de teléfono: +49251-8347283
- Correo electrónico: moritz.mertes@ukmuenster.de
Ubicaciones de estudio
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Münster, Alemania, 48149
- University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
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Contacto:
- Alexander Zarbock, MD
- Número de teléfono: +49251-8347255
- Correo electrónico: zarbock@uni-muenster.de
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Elective cardiac surgery using cardiopulmonary bypass
- Written informed consent
Exclusion Criteria:
- Pre-existing chronic kidney disease with an eGFR <20 ml/min/1,73m2
- Usage of VEGF-inhibitors
- Patients with pre-existing AKI within the last 30 days
Patients undergoing one of the following surgeries:
- Emergency surgery
- LVAD-implantation
- Patients after cardiac arrest requiring cardiopulmonary resuscitation within the last 6 months
- Patients on vasopressors, inotropes or mechanical circulatory support before surgery
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Elective cardiac surgical patients
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Periodo de tiempo: From baseline to postoperative day 3
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From baseline to postoperative day 3
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in VEGF levels between patients with and without chronic kidney disease
Periodo de tiempo: From Baseline to postoperative day 3
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From Baseline to postoperative day 3
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Difference in VEGF levels between patients with transient and persistent acute kidney injury (AKI) after cardiac surgery
Periodo de tiempo: Up to 30 days postoperatively
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Comparison of VEGF levels between patients with transient AKI (resolving within 48 hours of onset) and persistent AKI (lasting more than 48 hours), among patients who develop AKI within the first 3 postoperative days following cardiac surgery.
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Up to 30 days postoperatively
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Association of VEGF levels with length of ICU-stay
Periodo de tiempo: Up to 30 days postoperatively
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Association between perioperative VEGF levels and the duration of index intensive care unit (ICU) stay following cardiac surgery.
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Up to 30 days postoperatively
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Association of VEGF levels with length of hospital stay
Periodo de tiempo: Up to 30 days postoperatively
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Association between perioperative VEGF levels and the duration of index hospital stay following cardiac surgery.
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Up to 30 days postoperatively
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Association of VEGF levels with 30-day all-cause mortality
Periodo de tiempo: From enrolment to postoperative day 30
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From enrolment to postoperative day 30
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Association of VEGF levels with Major Adverse Kidney Events up to day 30 (MAKE30)
Periodo de tiempo: From enrolment to postoperative day 30
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From enrolment to postoperative day 30
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Association of VEGF plasma to urine ratio with postoperative AKI
Periodo de tiempo: From Baseline to postoperative day 3
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From Baseline to postoperative day 3
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
30 de abril de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AnIt26-03
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
Marco de tiempo para compartir IPD
Beginning 9 months and ending 36 months following article publication
Criterios de acceso compartido de IPD
With whom? Researchers who provide a methodologically sound proposal
By what mechanism will data be made available? Proposals should be directed to zarbock@uni-muenster.de. To gain access, data requestors will need to sign a data access agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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