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- Essai clinique NCT07803328
Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury (PROVE-AKI)
1 septembre 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Pas encore de recrutement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
220
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Alexander Zarbock, MD
- Numéro de téléphone: +49251-8347255
- E-mail: zarbock@uni-muenster.de
Sauvegarde des contacts de l'étude
- Nom: Moritz Mertes, MD
- Numéro de téléphone: +49251-8347283
- E-mail: moritz.mertes@ukmuenster.de
Lieux d'étude
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Münster, Allemagne, 48149
- University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
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Contact:
- Alexander Zarbock, MD
- Numéro de téléphone: +49251-8347255
- E-mail: zarbock@uni-muenster.de
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Elective cardiac surgical patients
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Délai: From baseline to postoperative day 3
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From baseline to postoperative day 3
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference in VEGF levels between patients with and without chronic kidney disease
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: From Baseline to postoperative day 3
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From Baseline to postoperative day 3
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
30 avril 2027
Achèvement de l'étude (Estimé)
1 mai 2027
Dates d'inscription aux études
Première soumission
27 août 2026
Première soumission répondant aux critères de contrôle qualité
1 septembre 2026
Première publication (Réel)
3 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 septembre 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AnIt26-03
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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