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

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ClinicalTrials.gov Identifier: NCT03754023
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Acute Kidney Injury Diagnostic Test: Urine-TIMP-IGFBP7 biomarker for AKI

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the ED who are determined to be at high risk for AKI.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754023


Contacts
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Contact: Salvatore Di Somma 00393483316131 salvatore.disomma@uniroma1.it
Contact: Paola Vietti 00393316703662 paola.vietti@greatnetwork.org

Locations
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Australia
Prince of Wales Hospital Not yet recruiting
Sidney, Australia, NSW2031
India
Yashoda Hospital Recruiting
Hyderabad, India, 500003
Korea, Republic of
Konkuk University Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05030
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Thailand
Rhamathibody Hospital Not yet recruiting
Bangkok, Thailand, 10400
Sponsors and Collaborators
GREAT Network Italy
Investigators
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Study Director: Salvatore Di Somma GREAT Network Italy

Publications:
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Responsible Party: GREAT Network Italy
ClinicalTrials.gov Identifier: NCT03754023     History of Changes
Other Study ID Numbers: BRAVA Study
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by GREAT Network Italy:
AKI
Biomarkers
Urine TIMP-IGFBP7
Emergency Department

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Acute Disease
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes