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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury

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.

• Study Type: Observational
• Enrollment (Actual): 1001

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Coastal Health
  • Manitoba
    • Winnepeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • Nova Scotia
    • Halifax,, Nova Scotia, Canada, B3H 1V7
      • Capitol District Health Authority
• United States
  • California
    • Los Angeles, California, United States, 90033
      • LA County / USC Medical Center
    • San Diego, California, United States, 92103
      • University of California, San Diego
    • San Francisco, California, United States, 94110
      • UC San Francisco General Hospital
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Sleep Allergy and Lungs
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Kansas University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Petoskey, Michigan, United States, 49770
      • Cardiac and Vascular Research Center of Northern Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Montana
    • Missoula, Montana, United States, 59802
      • International Heart Institute of Montana
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook University Hospital
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals, Case Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center
    • Seattle,, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All comers ordered to be admitted to the ICU.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Prior to or within 72 hours.

Collaborators and Investigators

• Sponsor: Biosite
• Investigators: Principal Investigator: John Kellum, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: December 9, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: BSTE-0409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO