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Completed

NCT Number: NCT01573962

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Astute Medical, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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