FGF23 as a Marker of Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693962
• Other study ID #: OAIC 868/17
• Status: Recruiting
• Start date: April 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2020
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Ischemia
• Kidney Ischemia
• Wounds and Injuries

Intervention

Diagnostic Test:
• Plasmatic Fibroblast Growth Factor-23 by means of ELISA
Plasma levels of FGF-23 will be measured by ELISA

Locations

Country	Name	City	State
Chile	Hospital Clinic Universidad de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury	Patients that develop postoperative acute kidney injury	72 hours