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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.
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:
Primary outcomes:
Secondary outcomes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critical Care Patients | Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization | Determination of number of days of hospitalization (in ICU and overall hospitalization) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Development of acute kidney injury | Evaluation of development of AKI, using KDIGO creatinine criteria | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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Patients admitted in Critical Care Unit with diagnosis of severe sepsis/septic shock.
Pregnant women and transplanted patients are excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Luis Toro, MD | University of Chile Clinical Hospital | Principal Investigator |
| Luis Michea, MD PhD | University of Chile | Principal Investigator |
| Carlos Romero, MD | University of Chile Clinical Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chile Clinical Hospital | Santiago | RM | 8380456 | Chile |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Venous blood samples will be obtained. Serum samples will be extracted, with elimination of other material. Serum will be stored at -20ÂșC until plasma molecules determination was performed by ELISA technique.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |