FGF23 as a Marker of Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2021-12-01

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.

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Detailed Description

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Conditions

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Acute Kidney Injury Kidney Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Partial Nephrectomy (PN)

Patients that will undergo PN with a transient and controlled renal ischemia injury using a renal artery clamping.

Plasmatic Fibroblast Growth Factor-23 by means of ELISA

Intervention Type DIAGNOSTIC_TEST

Plasma levels of FGF-23 will be measured by ELISA

Hemicolectomy (HC)

Patients who will undergo HC, as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC.

Plasmatic Fibroblast Growth Factor-23 by means of ELISA

Intervention Type DIAGNOSTIC_TEST

Plasma levels of FGF-23 will be measured by ELISA

Nephrolithotomy (NL)

Patients who undergo NL as non-renal ischemia surgery controls but with kidney physical injury

Plasmatic Fibroblast Growth Factor-23 by means of ELISA

Intervention Type DIAGNOSTIC_TEST

Plasma levels of FGF-23 will be measured by ELISA

Interventions

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Plasmatic Fibroblast Growth Factor-23 by means of ELISA

Plasma levels of FGF-23 will be measured by ELISA

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes