FGF23 as a Marker of Acute Kidney Injury

• Conditions: Acute Kidney Injury; Kidney Ischemia
• Interventions: Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA

• Registration Number: NCT04693962
• Lead Sponsor: University of Chile

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2020-05-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Partial Nephrectomy (PN)	Plasmatic Fibroblast Growth Factor-23 by means of ELISA	Patients that will undergo PN with a transient and controlled renal ischemia injury using a renal artery clamping.
Hemicolectomy (HC)	Plasmatic Fibroblast Growth Factor-23 by means of ELISA	Patients who will undergo HC, as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC.
Nephrolithotomy (NL)	Plasmatic Fibroblast Growth Factor-23 by means of ELISA	Patients who undergo NL as non-renal ischemia surgery controls but with kidney physical injury

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	72 hours	Patients that develop postoperative acute kidney injury

Trial Locations

Locations (1)

Hospital Clinic Universidad de Chile; 🇨🇱 Santiago, Chile