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

Acute Kidney Injury Clinical Trial

— REAL-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294228
• Other study ID #: BSTE-0409
• Status: Completed
• Phase: N/A
• First received: February 10, 2011
• Last updated: January 28, 2015
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: December 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Countries where clinical trial is conducted

United States,  Canada,