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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03754023




Registration number
NCT03754023
Ethics application status
Date submitted
12/11/2018
Date registered
27/11/2018

Titles & IDs
Public title
Biomarker Rule in/Out in Patients With Acute Diseases for Validation of AKI (BRAVA) Acute Kidney Injury
Scientific 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
Secondary ID [1] 0 0
BRAVA Study
Universal Trial Number (UTN)
Trial acronym
BRAVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Urine-TIMP-IGFBP7 biomarker for AKI

Diagnosis / Prognosis: Urine-TIMP-IGFBP7 biomarker for AKI
Urine-TIMP-IGFBP7 biomarker for AKI
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
48 hours
Secondary outcome [1] 0 0
Overall length in days of hospital stay
Timepoint [1] 0 0
30 hours
Secondary outcome [2] 0 0
Incidence of chronic kidney disease (CKD)
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Overall mortality
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Regional (different countries in Asia Pacific Region) incidence of AKI in a cohort of patients presenting to the ED with acute diseases
Timepoint [4] 0 0
48 hours

Eligibility
Key inclusion 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
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2019
Sample size
Target
Accrual to date
Final
818
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Sidney
Recruitment postcode(s) [1] 0 0
NSW2031 - Sidney
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Hyderabad
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore
Country [4] 0 0
Thailand
State/province [4] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Other
Name
GREAT Network Italy
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Salvatore Di Somma
Address 0 0
GREAT Network Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan to make IPD available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03754023