Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU
REAL-ICU
1 other identifier
observational
1,001
2 countries
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
February 2, 2017
CompletedFebruary 2, 2017
December 1, 2016
2.1 years
February 10, 2011
August 26, 2016
December 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
All comers ordered to be admitted to the ICU.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
LA County / USC Medical Center
Los Angeles, California, 90033, United States
University of California, San Diego
San Diego, California, 92103, United States
UC San Francisco General Hospital
San Francisco, California, 94110, United States
St. Francis Sleep Allergy and Lungs
Clearwater, Florida, 33765, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Kansas University Medical Center
Kansas City, Kansas, 66103, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
International Heart Institute of Montana
Missoula, Montana, 59802, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Mount Sinai Hospital
New York, New York, 10029, United States
SUNY Stony Brook University Hospital
Stony Brook, New York, 11794, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University Hospitals, Case Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Providence Regional Medical Center
Everett, Washington, 98201, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9, Canada
St. Boniface Hospital
Winnepeg, Manitoba, R2H 2A6, Canada
Capitol District Health Authority
Halifax, Nova Scotia, B3H 1V7, Canada
Biospecimen
Plasma Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Affairs
- Organization
- Alere San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
John Kellum, MD
University of Pittsburgh Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2013
Study Completion
December 1, 2014
Last Updated
February 2, 2017
Results First Posted
February 2, 2017
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share