Acute Kidney InjuryPROVE-AKINCT07803328
Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury
An observational study of Acute Kidney Injury and Cardiac Surgery Associated - Acute Kidney Injury, run by Universität Münster at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery Associated - Acute Kidney Injury
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass
Who may be able to join
- Age ≥ 18 years
- Elective cardiac surgery using cardiopulmonary bypass
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
Münster, 48149
Alexander Zarbock, MD, +49251-8347255, zarbock@uni-muenster.de
About this study
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).
Read the 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.
- Keywords
- vegf, vascular endothelial growth factor
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elective cardiac surgical patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Measured: From baseline to postoperative day 3
Secondary outcomes (7)
Difference in VEGF levels between patients with and without chronic kidney disease
Measured: From Baseline to postoperative day 3
Difference in VEGF levels between patients with transient and persistent acute kidney injury (AKI) after cardiac surgery
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.
Measured: Up to 30 days postoperatively
Association of VEGF levels with length of ICU-stay
Association between perioperative VEGF levels and the duration of index intensive care unit (ICU) stay following cardiac surgery.
Measured: Up to 30 days postoperatively
Association of VEGF levels with length of hospital stay
Association between perioperative VEGF levels and the duration of index hospital stay following cardiac surgery.
Measured: Up to 30 days postoperatively
Association of VEGF levels with 30-day all-cause mortality
Measured: From enrolment to postoperative day 30
Association of VEGF levels with Major Adverse Kidney Events up to day 30 (MAKE30)
Measured: From enrolment to postoperative day 30
Association of VEGF plasma to urine ratio with postoperative AKI
Measured: From Baseline to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803328
- Sponsor's protocol ID
- AnIt26-03
- Acronym
- PROVE-AKI
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07803328
- Acronym / sponsor ID
- PROVE-AKI / AnIt26-03
- Keywords
- vegf, vascular endothelial growth factor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective cardiac surgical patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Elective cardiac surgery using cardiopulmonary bypass
- Written informed consent
Key exclusion criteria (8 listed)
- 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:
- Patients after cardiac arrest requiring cardiopulmonary resuscitation within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury
Time frame: From baseline to postoperative day 3
7 secondary outcomes
Difference in VEGF levels between patients with and without chronic kidney disease
Time frame: 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
Association of VEGF levels with length of ICU-stay
Time frame: Up to 30 days postoperatively
Association of VEGF levels with length of hospital stay
Time frame: Up to 30 days postoperatively
Association of VEGF levels with 30-day all-cause mortality
Time frame: 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
Association of VEGF plasma to urine ratio with postoperative AKI
Time frame: From Baseline to postoperative day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Cardiac Surgery Associated - Acute Kidney Injury, run by Universität Münster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Zarbock, MD (+49251-8347255, zarbock@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury (time frame: From baseline to postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.