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

GREAT Network Italy

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Diagnostic Test: Urine-TIMP-IGFBP7 biomarker for AKI

Study type: Observational

Funder types: NETWORK

Identifiers

NCT03754023

BRAVA Study

Details and patient eligibility

About

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

Full description

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.

Enrollment: 818 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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