Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury (PROVE-AKI)

September 1, 2026 updated by: 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).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Münster, Germany, 48149
        • University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Elective cardiac surgery using cardiopulmonary bypass
  3. Written informed consent

Exclusion Criteria:

  1. Pre-existing chronic kidney disease with an eGFR <20 ml/min/1,73m2
  2. Usage of VEGF-inhibitors
  3. Patients with pre-existing AKI within the last 30 days
  4. Patients undergoing one of the following surgeries:

    1. Emergency surgery
    2. LVAD-implantation
  5. Patients after cardiac arrest requiring cardiopulmonary resuscitation within the last 6 months
  6. Patients on vasopressors, inotropes or mechanical circulatory support before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Elective cardiac surgical patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Time Frame: From baseline to postoperative day 3
From baseline to postoperative day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in VEGF levels between patients with and without chronic kidney disease
Time Frame: 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
Time Frame: 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.
Up to 30 days postoperatively
Association of VEGF levels with length of ICU-stay
Time Frame: Up to 30 days postoperatively
Association between perioperative VEGF levels and the duration of index intensive care unit (ICU) stay following cardiac surgery.
Up to 30 days postoperatively
Association of VEGF levels with length of hospital stay
Time Frame: Up to 30 days postoperatively
Association between perioperative VEGF levels and the duration of index hospital stay following cardiac surgery.
Up to 30 days postoperatively
Association of VEGF levels with 30-day all-cause mortality
Time Frame: From enrolment to postoperative day 30
From enrolment to postoperative day 30
Association of VEGF levels with Major Adverse Kidney Events up to day 30 (MAKE30)
Time Frame: From enrolment to postoperative day 30
From enrolment to postoperative day 30
Association of VEGF plasma to urine ratio with postoperative AKI
Time Frame: From Baseline to postoperative day 3
From Baseline to postoperative day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AnIt26-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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