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Completed

NCT Number: NCT03754023

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

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

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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital, Sydney, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine-TIMP-IGFBP7 biomarker for AKI

Diagnostic Test

Urine-TIMP-IGFBP7 biomarker for AKI

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.

    Time frame: 48 hours

Secondary outcomes

  1. Overall length in days of hospital stay

    Time frame: 30 hours

  2. Incidence of chronic kidney disease (CKD)

    Time frame: 30 days

  3. Overall mortality

    Time frame: 30 days

  4. Regional (different countries in Asia Pacific Region) incidence of AKI in a cohort of patients presenting to the ED with acute diseases

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

GREAT Network Italy

Network

Registry information

Official study 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

Acronym: BRAVA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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