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

NCT03754023 | Completed FDA Device

• 1 other identifier: BRAVA Study
• Study Type: observational
• Target: 818
• Locations: 5 countries
• Sites: 5

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

Conditions

Acute Kidney Injury

Keywords

AKI; Biomarkers; Urine TIMP-IGFBP7; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

Urine-TIMP-IGFBP7 biomarker for AKI DIAGNOSTIC_TEST

Urine-TIMP-IGFBP7 biomarker for AKI

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the ED who are determined to be at high risk for AKI.

You may qualify if:

• 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

You may not qualify if:

• Age \< 21 years.
• Unable to give informed consent
• Undergoing hemodialysis or peritoneal dialysis
• Pregnancy
• Terminal illness with \< 6 months prognosis
• Do-not-resuscitate status

Sponsors & Collaborators

• GREAT Network Italy: lead

Study Sites (5)

Prince of Wales Hospital

Sydney, NSW2031, Australia

Location

Yashoda Hospital

Hyderabad, 500003, India

Location

National University Hospital

Singapore, 119074, Singapore

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Rhamathibody Hospital

Bangkok, 10400, Thailand

Location

Related Publications (3)

• Ostermann M, Joannidis M. Acute kidney injury 2016: diagnosis and diagnostic workup. Crit Care. 2016 Sep 27;20(1):299. doi: 10.1186/s13054-016-1478-z.

  PMID: 27670788 BACKGROUND

• Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore 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.

  PMID: 26162677 BACKGROUND

• Wetz AJ, Richardt EM, Wand S, Kunze N, Schotola H, Quintel M, Brauer 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(1):3. doi: 10.1186/s13054-014-0717-4.

  PMID: 25560277 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Acute Kidney Injury; Emergencies

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Di Somma

  GREAT Network Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 27, 2018
• Study Start: November 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 9, 2021

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); KR (1); IN (1); TH (1); AU (1)