Role of FGF-23 as a Prognosis Biomarker in Intensive Care Patients
Condition: Sepsis; Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Observational [Patient Registry]

Summary: 
      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.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      Venous blood samples will be obtained. Serum samples will be extracted, with elimination of
      other material. Serum will be stored at -20ºC until plasma molecules determination was
      performed by ELISA technique.