FGF23 as a Marker of Acute Kidney Injury

December 30, 2020 updated by: Nicolas Valls Jimenez, University of Chile

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Hospital Clinic Universidad de Chile
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA
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
Diagnostic test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA
Plasma levels of FGF-23 will be measured by ELISA

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

May 30, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAIC 868/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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