Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU

Completed

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT01294228

Run by

Abbott RDx Cardiometabolic

People needed

1001

Starts

2011-03-01

Expected to finish

2014-12-01

Last updated by the study team

2017-02-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• LA County / USC Medical Center — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• UC San Francisco General Hospital — San Francisco, California, United States
• St. Francis Sleep Allergy and Lungs — Clearwater, Florida, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Cardiac and Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• International Heart Institute of Montana — Missoula, Montana, United States
• Cooper University Hospital — Camden, New Jersey, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• SUNY Stony Brook University Hospital — Stony Brook, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• University Hospitals, Case Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Providence Regional Medical Center — Everett, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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