We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573962
First Posted: April 10, 2012
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astute Medical, Inc.
  Purpose
The objective of this sample collection study is to collect blood and urine samples. This study is observational and will have no impact on the medical management of the subject.

Condition
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury

Further study details as provided by Astute Medical, Inc.:

Primary Outcome Measures:
  • A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury [ Time Frame: 04/1/2012 to 3/29/13 ]

Enrollment: 420
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients at risk of AKI.
Criteria

Inclusion Criteria:

  • Males and females 21 years of age or older
  • Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
  • Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
  • Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment
  • Expected to remain in the ICU for at least 48 hours after enrollment
  • Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
  • At least one of the following acute conditions documented within 24 hours prior to enrollment
  • Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)
  • Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required
  • Subject (or authorized representative) able and willing to provide written informed consent for study participation.

Exclusion Criteria:

  • Special populations including women with known pregnancy, prisoners or institutionalized individuals
  • Previous renal transplantation
  • Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3
  • Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
  • Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)
  • Subjects with a history of Chronic Kidney Disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573962


  Show 23 Study Locations
Sponsors and Collaborators
Astute Medical, Inc.
Investigators
Principal Investigator: John Kellum, Ph.D. Professor, Critical Care Medicine, University of Pittsburgh
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astute Medical, Inc.
ClinicalTrials.gov Identifier: NCT01573962     History of Changes
Other Study ID Numbers: Topaz
First Submitted: April 6, 2012
First Posted: April 10, 2012
Last Update Posted: October 15, 2014
Last Verified: September 2013

Keywords provided by Astute Medical, Inc.:
Kidney Renal

Additional relevant MeSH terms:
Wounds and Injuries
Critical Illness
Acute Kidney Injury
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases