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Completed

NCT Number: NCT01801501

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.

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Key information

Conditions

Sepsis Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

15 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chile Clinical Hospital

Santiago, RM, 8380456, Chile

About this study

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:

  • - 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.
  • - Evaluation of a larger sample, to determinate the impact of FGF-23 to predict primary outcomes.

Primary outcomes:

  • - Development of acute kidney injury
  • - Severity of AKI, determinate by AKIN classification
  • - In-hospital mortality

Secondary outcomes:

  • - Requirements of renal replacement therapy
  • - Requirements of mechanical ventilation
  • - Requirements of vasoactive drugs
  • - 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission in Critical Care Unit
  • Sepsis

Exclusion criteria

  • Pregnancy
  • Organ transplantation

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 30 days and 1 year

    Determination of overall survival during the first 30 days and 1 year after admission

Secondary outcomes

  1. Duration of hospitalization

    Time frame: 30 days

    Determination of number of days of hospitalization (in ICU and overall hospitalization)

Other outcomes

  1. Development of acute kidney injury

    Time frame: 30 days

    Evaluation of development of AKI, using KDIGO creatinine criteria

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2018
First posted
Feb 28, 2013
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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