FGF23 as a Marker of Acute Kidney Injury

Study Overview
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Brief Summary
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A partial nephrectomy (PN) preserves renal parenchyma with a proper oncology outcome. PN is performed during transitory ischemia to avoid massive bleeding during tumor resection. Nevertheless, the transitory ischemia might cause an acute kidney injury(AKI). AKI diagnose is based on the increase in plasma creatinine concentration and a decrease in urine output. However, both plasma creatinine concentration and diuresis are useful for the diagnose, but not in the detection of the risk patients. Therefore, there is considerable interest to find a biomarkers of kidney injury that allow clinicians to predict the development of AKI. Hence, we propose Fibroblastic Growth Factor-23 (FGF23) as a novel early biomarker to detect patients in risk to develop postoperative AKI after a PN. We will conduct an observational and prospective study in three different groups of patients: PN gropup, patients who underwent PN with a transient and controlled renal ischemia injury using a renal artery clamping; Hemicolectomy (HC) group, patients as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC; and Nephrolithotomy (NL) group, patients who underwent NL, as a control of kidney surgery with physical injury. In each patient, a time curve of plasmatic creatinine, blood urea nitrogen (BUN), and FGF23 were measure. Our study aims to describe the role of FGF23 as an early biomarker of AKI after PN, where patients are exposed to a controlled ischemic injury.

Official Title
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Fibroblast Growth Factor-23 as a Marker of Acute Kidney Injury After Partial Nephrectomy

Conditions
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Acute Kidney Injury, Kidney Ischemia

Intervention / Treatment
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* Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology physical status (ASA) I or II. Normal preoperative plasma creatinine level Baseline estimated glomerular filtration rate (eGFR) > 60 ml/min per 1.73 m2. Exclusion Criteria: History of chronic kidney disease Anemia Alterations in the parathormone or vitamin D axis Pregnant women Subjects with concomitant use of nephrotoxic drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Partial Nephrectomy (PN)<br>Patients that will undergo PN with a transient and controlled renal ischemia injury using a renal artery clamping. | Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA<br>* Plasma levels of FGF-23 will be measured by ELISA<br>|
| Hemicolectomy (HC)<br>Patients who will undergo HC, as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC. | Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA<br>* Plasma levels of FGF-23 will be measured by ELISA<br>|
| Nephrolithotomy (NL)<br>Patients who undergo NL as non-renal ischemia surgery controls but with kidney physical injury | Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA<br>* Plasma levels of FGF-23 will be measured by ELISA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | Patients that develop postoperative acute kidney injury | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Creatinine, Fibroblast Growth Factor-23