Biomarker Rule in/Out in Patients With Acute Diseases for Validation of AKI (BRAVA) Acute Kidney Injury

Study Overview
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Brief Summary
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The presence or development of AKI impacts on outcomes in patients presenting with acute conditions to the ED. As a result, treating physicians are often concerned with the risk of AKI and take such risk in consideration when making subsequent therapeutic and diagnostic decisions which may result in delaying or withholding therapeutic measures in order to prevent further kidney damage (i.e. avoid imaging studies with contrast media). If clinicians could be informed early that a patient is at minimal risk for AKI, they could deploy timely and optimal diagnostic and treatment procedures for the underlying disease of the patient without major concerns for causing or exacerbating kidney damage

Detailed Description
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In patients with acute diseases, it is mandatory for ED Physicians to immediately detect the presence of AKI or exclude; but unfortunately Serum creatinine (SCr) variations (based on KDIGO or AKIN criteria), take 24 to 48 hours to manifest the presence of acute renal ongoing damage. AKI is currently, infact, defined as an increase in SCr of 1.5-fold from baseline within 24 to 48 hours, and decrease in diuresis from admission in hospitalization, using KDIGO. As consequence, similarly to other biomarkers, such as troponins in acute coronary syndrome and D-dimer in pulmonary embolism, a laboratory test to rule in or rule out AKI is needed in critical patients in ED and our primary objective would be to evaluate the role of urine TIMP-IGFBP7 in this setting. Primary Objective of the BRAVA Study would be to evaluate the role of the urine biomarkers TIMP-IGFBP7 in predicting the occurrence of AKI in patients presenting to ED with different acute diseases and need for hospitalization.

Official Title
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The Potential Role of Biomarkers (Urine TIMP-IGFBP7) in Determining the Incidence of Acute Kidney Injury (AKI) in All-comers Patients Presenting to the Emergency Department With Acute Diseases

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Diagnostic Test: Urine-TIMP-IGFBP7 biomarker for AKI


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria Age ≥ 21 years >30% risk of developing AKI based on treating physicians' clinical evaluation AND/OR Presence of ONE OF the following conditions: Suspected or confirmed sepsis. Acute decompensated heart failure. Prolonged gastrointestinal losses from vomiting or diarrhea Major trauma Major bleeding (e.g. gastrointestinal, pulmonary, genitourinary) Severe burns Diabetic crisis (DKA, HHS) Decompensated liver cirrhosis Acute coronary syndrome Emergent need for iodinated contrast studies Shock from any cause Patient Exclusion Criteria Age < 21 years. Unable to give informed consent Undergoing hemodialysis or peritoneal dialysis Pregnancy Terminal illness with < 6 months prognosis Do-not-resuscitate status

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Urine-TIMP-IGFBP7 biomarker for AKI|Urine-TIMP-IGFBP7 biomarker for AKI|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of urine TIMP-IGFBP7 as early biomarker in ruling in or ruling out acute kidney damage in patients presenting to ED with acute diseases. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall length in days of hospital stay |  | 30 hours | 
| Incidence of chronic kidney disease (CKD) |  | 30 days | 
| Overall mortality |  | 30 days | 
| Regional (different countries in Asia Pacific Region) incidence of AKI in a cohort of patients presenting to the ED with acute diseases |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AKI, Biomarkers, Urine TIMP-IGFBP7, Emergency Department