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Neutrophil Gelatinase-associated Lipocalin (NGAL) Evaluation in Emergency Department (ED) All-Comers

This study has been completed.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00845741
First received: February 16, 2009
Last updated: January 20, 2011
Last verified: October 2010
History of Changes
  Purpose

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.


Condition
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NGAL Evaluation in ED All-Comers

Further study details as provided by Biosite:

Primary Outcome Measures:
  • Development of Acute Kidney Injury (AKI) [ Time Frame: 0 to 48hrs after ED presentation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the severity of AKI in patients using the NGAL device and clinical judgement. [ Time Frame: 0-48hrs after ED presentation ] [ Designated as safety issue: No ]

Enrollment: 700
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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 development of acute kidney injury (AKI) (sub clinical minimal changes in creatinine levels to complete failure resulting in kidney replacement therapy) in an all-comers population of patients presenting to the Emergency Department (ED) and designated for hospital admission.. The secondary objectives are to assess the utility of the Triage NGAL Test as an aid in the assessment of AKI severity in patients presenting to the ED, to determine if the combination of Triage NGAL measurements and clinical judgment can improve the early risk assessment for the development of AKI and to correlate Triage NGAL levels to patient outcomes.

Approximately 700 adults presenting to the ED and designated for admission to the hospital will be enrolled. The treating physician will note their preliminary ED diagnosis of AKI vs. no AKI (including prerenal azotemia, non-progressive chronic kidney disease (CKD) and preserved renal function) and their level of confidence in that diagnosis as a percentage following the initial exam.

EDTA anti-coagulated blood samples (for Triage NGAL Test) and blood samples for processing to serum (for Cystatin C test) will be collected and measured for NGAL and Cystatin C levels in all subjects at the following time points:

  • immediately upon decision to admit to the hospital from the ED [baseline],
  • at 6 and 12 hours after baseline draw
  • on days 1, 2 and 3 following admission to the hospital, and
  • on the day of hospital discharge (if the subject is hospitalized beyond day 3)

The results of these NGAL and Cystatin C assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.

Blood samples for unblinded standard of care assessment of serum creatinine (analyzed at the hospital's laboratory) will also be obtained:

  • in the ED [baseline],
  • on days 1, 2 and 3 following admission to the hospital, and
  • on the day of hospital discharge (if the subject is hospitalized beyond day 3)

Additional study specific blood samples for blinded assessment of serum creatinine (analyzed at the hospital's laboratory) will also be obtained:

• at 6 and 12 hours after baseline draw

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults presenting to the ED and designated for admission to the hospital will be enrolled.

Criteria

Inclusion Criteria:

  1. Males and females 18 years of age or older;
  2. Patients presenting to the ED who have been designated for hospital admission
  3. Ability to provide blood samples for baseline NGAL, Cystatin C and creatinine levels either prior to or at admission;
  4. Ability to provide written informed consent.

Exclusion Criteria:

  1. 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;
  2. Patients with urothelial malignancies;
  3. Patients not expected to be admitted and therefore unable to fulfil protocol requirements for blood collection out to day 3 post admission time points
  4. Prisoners or other institutionalized or vulnerable individuals;
  5. Participation in an interventional clinical study within the previous 30 days;
  6. Unlikely to be willing or able to comply with study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845741

Locations
Italy
Azienda Ospedaliera Sant'Andrea
Rome, Italy
Sponsors and Collaborators
Biosite
  More Information

No publications provided

Responsible Party: Kyle Fortner, CRA, Biosite, Inc.
ClinicalTrials.gov Identifier: NCT00845741     History of Changes
Other Study ID Numbers: BSTE-0408
Study First Received: February 16, 2009
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013