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Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury (PROVE-AKI)
1 september 2026 bijgewerkt door: 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).
Studie Overzicht
Toestand
Nog niet aan het werven
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
220
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Alexander Zarbock, MD
- Telefoonnummer: +49251-8347255
- E-mail: zarbock@uni-muenster.de
Studie Contact Back-up
- Naam: Moritz Mertes, MD
- Telefoonnummer: +49251-8347283
- E-mail: moritz.mertes@ukmuenster.de
Studie Locaties
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Münster, Duitsland, 48149
- University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
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Contact:
- Alexander Zarbock, MD
- Telefoonnummer: +49251-8347255
- E-mail: zarbock@uni-muenster.de
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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Elective cardiac surgical patients
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Tijdsspanne: From baseline to postoperative day 3
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From baseline to postoperative day 3
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Difference in VEGF levels between patients with and without chronic kidney disease
Tijdsspanne: From Baseline to postoperative day 3
|
From Baseline to postoperative day 3
|
|
|
Difference in VEGF levels between patients with transient and persistent acute kidney injury (AKI) after cardiac surgery
Tijdsspanne: Up to 30 days postoperatively
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: From enrolment to postoperative day 30
|
From enrolment to postoperative day 30
|
|
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Association of VEGF plasma to urine ratio with postoperative AKI
Tijdsspanne: From Baseline to postoperative day 3
|
From Baseline to postoperative day 3
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
30 april 2027
Studie voltooiing (Geschat)
1 mei 2027
Studieregistratiedata
Eerst ingediend
27 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 september 2026
Eerst geplaatst (Werkelijk)
3 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 september 2026
Laatste update ingediend die voldeed aan QC-criteria
1 september 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AnIt26-03
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
IPD-tijdsbestek voor delen
Beginning 9 months and ending 36 months following article publication
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .