- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07803328
Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury (PROVE-AKI)
1 settembre 2026 aggiornato da: 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).
Panoramica dello studio
Stato
Non ancora reclutamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Stimato)
220
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Alexander Zarbock, MD
- Numero di telefono: +49251-8347255
- Email: zarbock@uni-muenster.de
Backup dei contatti dello studio
- Nome: Moritz Mertes, MD
- Numero di telefono: +49251-8347283
- Email: moritz.mertes@ukmuenster.de
Luoghi di studio
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Münster, Germania, 48149
- University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
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Contatto:
- Alexander Zarbock, MD
- Numero di telefono: +49251-8347255
- Email: zarbock@uni-muenster.de
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Elective cardiac surgical patients
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Lasso di tempo: From baseline to postoperative day 3
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From baseline to postoperative day 3
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Difference in VEGF levels between patients with and without chronic kidney disease
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: From Baseline to postoperative day 3
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From Baseline to postoperative day 3
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
30 aprile 2027
Completamento dello studio (Stimato)
1 maggio 2027
Date di iscrizione allo studio
Primo inviato
27 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 settembre 2026
Primo Inserito (Effettivo)
3 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 settembre 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AnIt26-03
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
Periodo di condivisione IPD
Beginning 9 months and ending 36 months following article publication
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .