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Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU (REAL-ICU)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosite
ClinicalTrials.gov Identifier:
NCT01294228
First received: February 10, 2011
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU

Further study details as provided by Biosite:

Biospecimen Retention:   Samples Without DNA

Plasma Urine


Estimated Enrollment: 850
Study Start Date: March 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All comers ordered to be admitted to the ICU.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294228

  Show 28 Study Locations
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: John Kellum, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Biosite
ClinicalTrials.gov Identifier: NCT01294228     History of Changes
Other Study ID Numbers: BSTE-0409
Study First Received: February 10, 2011
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013