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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Azienda Ospedaliera Sant'Andrea

Rome, Italy