Clinical trial NCT01294228: Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU
Official title: Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 1001
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers ordered to be admitted to the ICU.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Prior to or within 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA County / USC Medical Center
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: UC San Francisco General Hospital
state: California
city: Clearwater
country: United States
facility: St. Francis Sleep Allergy and Lungs
state: Florida
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Missoula
country: United States
facility: International Heart Institute of Montana
state: Montana
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook University Hospital
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals, Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Everett
country: United States
facility: Providence Regional Medical Center
state: Washington
city: Seattle,
country: United States
facility: Swedish Medical Center
state: Washington
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
city: Winnepeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Halifax,
country: Canada
facility: Capitol District Health Authority
state: Nova Scotia
Study officials:
affiliation: University of Pittsburgh Medical Center
name: John Kellum, MD
role: PRINCIPAL_INVESTIGATOR
References: