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:
Information provided by (Responsible Party):
Astute Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01573962
First received: April 6, 2012
Last updated: September 23, 2013
Last verified: September 2013
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Astute Medical, Inc.

Additional 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
Study First Received: April 6, 2012
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Astute Medical, Inc.:
Kidney Renal

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

ClinicalTrials.gov processed this record on August 28, 2014