- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07803328
Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury (PROVE-AKI)
1. September 2026 aktualisiert von: 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).
Studienübersicht
Status
Noch keine Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
220
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Alexander Zarbock, MD
- Telefonnummer: +49251-8347255
- E-Mail: zarbock@uni-muenster.de
Studieren Sie die Kontaktsicherung
- Name: Moritz Mertes, MD
- Telefonnummer: +49251-8347283
- E-Mail: moritz.mertes@ukmuenster.de
Studienorte
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Münster, Deutschland, 48149
- University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
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Kontakt:
- Alexander Zarbock, MD
- Telefonnummer: +49251-8347255
- E-Mail: zarbock@uni-muenster.de
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Elective cardiac surgical patients
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Zeitfenster: From baseline to postoperative day 3
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From baseline to postoperative day 3
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Difference in VEGF levels between patients with and without chronic kidney disease
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: From Baseline to postoperative day 3
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From Baseline to postoperative day 3
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
30. April 2027
Studienabschluss (Geschätzt)
1. Mai 2027
Studienanmeldedaten
Zuerst eingereicht
27. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. September 2026
Zuerst gepostet (Tatsächlich)
3. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. September 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AnIt26-03
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
IPD-Sharing-Zeitrahmen
Beginning 9 months and ending 36 months following article publication
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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