Clinical trial NCT01868724: Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
Official title: Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Kidney Renal
Lead sponsor: Astute Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 362
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU Patients with AKI

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.
timeFrame: Day 1-7 of enrollment
Secondary outcomes:
measure: None at this time
timeFrame: 10 months
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Durham
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Innsbruck
country: Austria
city: Brussels
country: Belgium
city: Ghent
country: Belgium
city: Frankfurt
country: Germany
city: Madgeburg
country: Germany
city: Sabadelle
country: Spain
city: London
country: United Kingdom
city: London
country: United Kingdom
city: West Sussex
country: United Kingdom
Study officials:
affiliation: George Washington University
name: Lakhmir S Chawla, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koyner JL, Chawla LS, Bihorac A, Gunnerson KJ, Schroeder R, Demirjian S, Hodgson L, Frey JA, Wilber ST, Kampf JP, Kwan T, McPherson P, Kellum JA; RUBY investigators. Performance of a Standardized Clinical Assay for Urinary C-C Motif Chemokine Ligand 14 (CCL14) for Persistent Severe Acute Kidney Injury. Kidney360. 2022 Mar 24;3(7):1158-1168. doi: 10.34067/KID.0008002021. eCollection 2022 Jul 28.
citation: Hoste E, Bihorac A, Al-Khafaji A, Ortega LM, Ostermann M, Haase M, Zacharowski K, Wunderink R, Heung M, Lissauer M, Self WH, Koyner JL, Honore PM, Prowle JR, Joannidis M, Forni LG, Kampf JP, McPherson P, Kellum JA, Chawla LS; RUBY Investigators. Identification and validation of biomarkers of persistent acute kidney injury: the RUBY study. Intensive Care Med. 2020 May;46(5):943-953. doi: 10.1007/s00134-019-05919-0. Epub 2020 Feb 6.