Status:
COMPLETED
Neutrophil Gelatinase-associated Lipocalin (NGAL) Evaluation in Emergency Department (ED) All-Comers
Lead Sponsor:
Abbott RDx Cardiometabolic
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Brief Summary
This study is to evaluate the NGAL point of care device as an aid in the early risk assessment of AKI (acute kidney injury)in an All-Comers ED population.
Detailed Description
This is a multi-center prospective pilot clinical study to assess the utility of the Triage neutrophil gelatinase-associated lipocalin (NGAL) Test as an aid in the early risk assessment for developmen...
Eligibility Criteria
Inclusion
- Males and females 18 years of age or older;
- Patients presenting to the ED who have been designated for hospital admission
- Ability to provide blood samples for baseline NGAL, Cystatin C and creatinine levels either prior to or at admission;
- Ability to provide written informed consent.
Exclusion
- Known history of marked chronic renal insufficiency (e.g., usual serum creatinine ³ 3.0 mg/dL), on dialysis or RRT (either acute or chronic) or in imminent need of dialysis or RRT at enrollment;
- Patients with urothelial malignancies;
- Patients not expected to be admitted and therefore unable to fulfil protocol requirements for blood collection out to day 3 post admission time points
- Prisoners or other institutionalized or vulnerable individuals;
- Participation in an interventional clinical study within the previous 30 days;
- Unlikely to be willing or able to comply with study procedures.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00845741
Start Date
February 1 2009
End Date
August 1 2010
Last Update
January 24 2011
Active Locations (1)
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1
Azienda Ospedaliera Sant'Andrea
Rome, Italy