Biomarker Rule in/Out in Patients With Acute Diseases for Validation of AKI (BRAVA) Acute Kidney Injury
- Conditions
- Acute Kidney Injury
- Registration Number
- NCT03754023
- Lead Sponsor
- GREAT Network Italy
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 818
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence of chronic kidney disease (CKD) 30 days Overall length in days of hospital stay 30 hours Regional (different countries in Asia Pacific Region) incidence of AKI in a cohort of patients presenting to the ED with acute diseases 48 hours Overall mortality 30 days
Trial Locations
- Locations (5)
Yashoda Hospital
🇮🇳Hyderabad, India
Prince of Wales Hospital
🇦🇺Sidney, Australia
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
National University Hospital
🇸🇬Singapore, Singapore
Rhamathibody Hospital
🇹🇭Bangkok, Thailand