Skip to main content
OpenTrials
Completed

NCT Number: NCT01868724

Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).

Completed

Looking for future studies?

Notify Me

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

Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

a.

  • Males and females 21 years of age or older
  • Receiving care in an intensive care unit
  • Expected to remain in the ICU for at least 48 hours after enrollment
  • Use of indwelling urinary catheter as standard care at the time of enrollment
  • Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the first sample collection
  • First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria
  • Written informed consent provided by patient or legally authorized representative (LAR)

Exclusion criteria

  • Prior kidney transplantation
  • Comfort-measures-only status
  • Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
  • History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
  • Special populations, pregnant women, prisoners or institutionalized individuals
  • Patient meets any of the following:
  • Active bleeding with an anticipated need for > 4 units PRBC in a day
  • Hemoglobin < 7 g/dL
  • Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes

Treatment and study plan

Primary outcomes

  1. Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.

    Time frame: Day 1-7 of enrollment

    This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days.

Secondary outcomes

  1. None at this time

    Time frame: 10 months

    There are no secondary outcomes measures planned at this time

Sponsors and collaborators

Lead sponsor

Astute Medical, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Mar 13, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.