Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury (PROVE-AKI)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Alexander Zarbock, MD
- Phone Number: +49251-8347255
- Email: zarbock@uni-muenster.de
Study Contact Backup
- Name: Moritz Mertes, MD
- Phone Number: +49251-8347283
- Email: moritz.mertes@ukmuenster.de
Study Locations
-
-
-
Münster, Germany, 48149
- University Muenster, University Hospital Muenster, Department of Anesthesiology, Intensive Care and Pain Medicineperative
-
Contact:
- Alexander Zarbock, MD
- Phone Number: +49251-8347255
- Email: zarbock@uni-muenster.de
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
Elective cardiac surgical patients
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AnIt26-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.