Role of FGF-23 as a Prognosis Biomarker in Intensive Care Patients

The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.

Study Overview

• Status: Completed
• Conditions: Sepsis; Acute Kidney Injury

Detailed Description

Observational study of patients admitted in the Critical Care Unit (CCU) of University of Chile Clinical Hospital, admitted with diagnosis of severe sepsis/septic shock.

Exclusion criteria: Pregnancy, organ transplantation. Informed consent is solicited to patients before admission in study. If the patient cannot give it because of his/her clinical condition, it will be solicited to a patient representative.

After admission in CCU and achievement of informed consent, a venous blood sample will be obtained, to determinate plasmatic levels of Fibroblast Growth Factor 23 (FGF-23). New samples will be obtained at 24 and 48 hours after admission. Determination of FGF-23 will be performed by ELISA technique in Integrated Physiology laboratory.

Demographics, clinical and biochemical data will also be obtained. The data will be collected by the Principal Investigator. Confidentially of all data will be preserved during and after the completion of the study.

The study is divided in 2 parts:

1. - Evaluation of a sample of 14 patients to determinate the impact of FGF-23 to predict presence and severity of Acute Kidney Injury (AKI), and to estimate sample size to predict primary outcomes.
2. - Evaluation of a larger sample, to determinate the impact of FGF-23 to predict primary outcomes.

Primary outcomes:

1. - Development of acute kidney injury
2. - Severity of AKI, determinate by AKIN classification
3. - In-hospital mortality

Secondary outcomes:

1. - Requirements of renal replacement therapy
2. - Requirements of mechanical ventilation
3. - Requirements of vasoactive drugs
4. - Duration of ICU stay and hospital stay

As a post-hoc analysis, we performed a measurement of a combined biomarker, including FGF-23 and other 2 biomarkers, Klotho and Erythropoietin, measured in blood samples, to determinate its predictive capacity for AKI diagnosis and mortality.

The protocol was approved by the Ethical Committee of University of Chile Clinical Hospital. The study is monitored by the Clinical Investigation Support Office (OAIC) of the hospital.

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 8380456
      • University of Chile Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 89 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock.

Pregnant women and transplanted patients are excluded.

Description

Inclusion Criteria:

• Admission in Critical Care Unit
• Sepsis

Exclusion Criteria:

• Pregnancy
• Organ transplantation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Critical Care Patients; Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Determination of overall survival during the first 30 days and 1 year after admission	30 days and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization	Determination of number of days of hospitalization (in ICU and overall hospitalization)	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of acute kidney injury	Evaluation of development of AKI, using KDIGO creatinine criteria	30 days

Collaborators and Investigators

• Sponsor: University of Chile
• Investigators: Principal Investigator: Luis Toro, MD, University of Chile Clinical Hospital; Principal Investigator: Luis Michea, MD PhD, University of Chile; Study Chair: Carlos Romero, MD, University of Chile Clinical Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: AKI-FGF23-012