Biomarker Rule in/Out in Patients With Acute Diseases for Validation of AKI (BRAVA) Acute Kidney Injury
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Patient Inclusion Criteria
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Age ≥ 21 years
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30% risk of developing AKI based on treating physicians' clinical evaluation AND/OR
Presence of ONE OF the following conditions:
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Suspected or confirmed sepsis.
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Acute decompensated heart failure.
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Prolonged gastrointestinal losses from vomiting or diarrhea
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Major trauma
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Major bleeding (e.g. gastrointestinal, pulmonary, genitourinary)
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Severe burns
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Diabetic crisis (DKA, HHS)
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Decompensated liver cirrhosis
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Acute coronary syndrome
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Emergent need for iodinated contrast studies
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Shock from any cause
Patient Exclusion Criteria
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Age < 21 years.
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Unable to give informed consent
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Undergoing hemodialysis or peritoneal dialysis
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Pregnancy
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Terminal illness with < 6 months prognosis
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Do-not-resuscitate status
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prince of Wales Hospital | Sidney | Australia | NSW2031 | |
| 2 | Yashoda Hospital | Hyderabad | India | 500003 | |
| 3 | Konkuk University Medical Center | Seoul | Korea, Republic of | 05030 | |
| 4 | National University Hospital | Singapore | Singapore | 119074 | |
| 5 | Rhamathibody Hospital | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- GREAT Network Italy
Investigators
- Study Director: Salvatore Di Somma, GREAT Network Italy
Study Documents (Full-Text)
None provided.More Information
Publications
- Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honoré PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Ostermann M, Joannidis M. Acute kidney injury 2016: diagnosis and diagnostic workup. Crit Care. 2016 Sep 27;20(1):299. Review.
- Wetz AJ, Richardt EM, Wand S, Kunze N, Schotola H, Quintel M, Bräuer A, Moerer O. Quantification of urinary TIMP-2 and IGFBP-7: an adequate diagnostic test to predict acute kidney injury after cardiac surgery? Crit Care. 2015 Jan 6;19:3. doi: 10.1186/s13054-014-0717-4.
- BRAVA Study