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

NCT ID: NCT01294228

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1001 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott RDx Cardiometabolic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Kellum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

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

Vancouver Coastal Health

Vancouver, British Columbia, Canada

St. Boniface Hospital

Winnepeg, Manitoba, Canada

Capitol District Health Authority

Halifax, Nova Scotia, Canada

Countries

United States; Canada

Other Identifiers

BSTE-0409

Identifier Type: -

Identifier Source: org_study_id