Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU (REAL-ICU)

This study has been completed.
Information provided by (Responsible Party):
Biosite Identifier:
First received: February 10, 2011
Last updated: December 9, 2016
Last verified: December 2016
This is a multi-center, prospective, observational study of patients that are admitted to the intensive care unit (ICU). This study does not include any treatment or intervention and it is considered Nonsignificant Risk.

Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU

Further study details as provided by Biosite:

Primary Outcome Measures:
  • The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting. [ Time Frame: Prior to or within 72 hours. ]
    The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.

Biospecimen Retention:   Samples Without DNA
Plasma Urine

Enrollment: 1001
Study Start Date: March 2011
Study Completion Date: December 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The study will be conducted in two phases. Phase One is specimen acquisition and subject diagnosis adjudication. Phase Two is biomarker testing.

Phase One

Approximately 850 adults admitted to general ICUs will be enrolled within 12 hours of receipt of ICU admission orders. Study specific whole blood and urine specimens will be collected.

There is an Adjudication Committee for this study. This committee is comprised of qualified, board-certified nephrologists.

Phase Two

During Phase Two, the plasma specimens will be divided amongst three clinical sites representative of the intended end users of this assay, and tested under a separate testing protocol.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All comers ordered to be admitted to the ICU.

Inclusion Criteria:

  • Subjects must be 21 years of age or older.
  • Subjects must be admitted to an Intensive Care Unit (medical or surgical) and must be enrolled into this study within 12 hours of receipt of ICU admission orders.
  • Subjects must be assessed as likely to be alive in the ICU for a minimum of 48 hours after enrollment.
  • The following plasma/serum creatinine values must be available:
  • Subjects that are admitted to the ICU following an elective surgery or procedure must have at least one pre-surgical/ pre-procedure creatinine value obtained in the 7 days prior to presentation to the ICU.
  • Subjects that are admitted to the ICU for any reason other than following an elective surgery or procedure must have at least one creatinine value obtained greater than 7 days and up to 6 months prior to presentation to the ICU.

Exclusion Criteria

  • Subjects either receiving or in imminent need of Renal Replacement Therapy.
  • Subjects with evidence of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 (according to the 4-variable MDRD22).
  • Subjects with any obstructive uropathy at the time of presentation to the ICU.
  • Subjects with any known urothelial, urological or kidney malignancies.
  • Subjects that have had any urologic procedure or surgery immediately prior to admission to the ICU.
  • Subjects that have had any renal transplant or nephrectomy.
  • Subjects that have had cardiovascular surgery involving cardiopulmonary bypass within the previous 7 days.
  • Subjects that have participated in an interventional clinical study within the previous 30 days including studies with any investigational and non-investigational drugs.
  • The inability to obtain written Informed Consent from the subject or an authorized representative.
  • Subjects that have been previously enrolled in this study during a prior admission to the ICU.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01294228

  Show 28 Study Locations
Sponsors and Collaborators
Principal Investigator: John Kellum, MD University of Pittsburgh
  More Information

Responsible Party: Biosite Identifier: NCT01294228     History of Changes
Other Study ID Numbers: BSTE-0409
Study First Received: February 10, 2011
Results First Received: August 26, 2016
Last Updated: December 9, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on April 28, 2017