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

Acute Kidney Injury Clinical Trial

— BRAVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754023
• Other study ID #: BRAVA Study
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: November 2018
• Source: GREAT Network Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: November 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Kidney Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Australia	Prince of Wales Hospital	Sidney
India	Yashoda Hospital	Hyderabad
Korea, Republic of	Konkuk University Medical Center	Seoul
Singapore	National University Hospital	Singapore
Thailand	Rhamathibody Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
GREAT Network Italy

Countries where clinical trial is conducted

Australia,  India,  Korea, Republic of,  Singapore,  Thailand, 

References & Publications (3)

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. — View Citation

Ostermann M, Joannidis M. Acute kidney injury 2016: diagnosis and diagnostic workup. Crit Care. 2016 Sep 27;20(1):299. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall length in days of hospital stay		30 hours
Secondary	Incidence of chronic kidney disease (CKD)		30 days
Secondary	Overall mortality		30 days
Secondary	Regional (different countries in Asia Pacific Region) incidence of AKI in a cohort of patients presenting to the ED with acute diseases		48 hours