Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

NCT ID: NCT01868724

Last Updated: 2015-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

362 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astute Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lakhmir S Chawla, M.D.

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

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Washington D.C., District of Columbia, United States

Site Status

Gainesville, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Baltimore, Massachusetts, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Durham, North Carolina, United States

Site Status

Akron, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

Site Status

Innsbruck, , Austria

Site Status

Brussels, , Belgium

Site Status

Ghent, , Belgium

Site Status

Frankfurt, , Germany

Site Status

Madgeburg, , Germany

Site Status

Sabadelle, , Spain

Site Status

London, , United Kingdom

Site Status

London, , United Kingdom

Site Status

West Sussex, , United Kingdom

Site Status

Countries

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United States Austria Belgium Germany Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35919538 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32025755 (View on PubMed)

Other Identifiers

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Ruby

Identifier Type: -

Identifier Source: org_study_id

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