FGF23 as a Marker of Acute Kidney Injury

NCT04693962 | Unknown DMC

• 1 other identifier: OAIC 868/17
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Kidney Ischemia

Keywords

Acute kidney injury; Creatinine; Fibroblast Growth Factor-23

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  Patients that develop postoperative acute kidney injury

  72 hours

Study Arms (3)

Partial Nephrectomy (PN)

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

Hemicolectomy (HC)

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

Nephrolithotomy (NL)

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

Interventions

Plasmatic Fibroblast Growth Factor-23 by means of ELISA DIAGNOSTIC_TEST

Plasma levels of FGF-23 will be measured by ELISA

Hemicolectomy (HC); Nephrolithotomy (NL); Partial Nephrectomy (PN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnose that requires any of three surgerys: Partial Nephrectomy, Hemicolectomy, Nephrolithotomy

You may qualify if:

• 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.

You may not qualify if:

• History of chronic kidney disease
• Anemia
• Alterations in the parathormone or vitamin D axis
• Pregnant women
• Subjects with concomitant use of nephrotoxic drugs.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clinic Universidad de Chile

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: April 1, 2017
• Primary Completion: May 30, 2020
• Study Completion: December 1, 2021
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)