Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT01209169
• Lead Sponsor: Astute Medical, Inc.

Brief Summary

The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-27
• Primary Completion: 2012-04
• Status Verified: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 890

Inclusion Criteria

Males and females 21 years of age or older;

Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24 hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 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 within 24 hours prior to enrollment:

(Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required).

Patient (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 acutely worsening renal function prior to enrollment (e.g., any category of RIFLE criteria. 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);Patient meets any of the following:Active bleeding with an anticipated need for > 4 units PRBC;Hemoglobin < 7 g/dL;Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.	10/2010 to 2/2013	Primary outcome measure: Identification and Validation of Biomarkers from Acutely ill patients at risk for AKI. (N=744) Secondary outcomes including follow-up (N=890).

Trial Locations

Locations (35)

Maricopa Intergrated Health System; 🇺🇸 Phoenix, Arizona, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Bruce W. Carter Department of Veterans Affairs Medical Center; 🇺🇸 Miami, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Joseph M. Still Research Foundation, Inc.; 🇺🇸 Augusta, Georgia, United States

University of Chicago Medical Center Section of Nephrology; 🇺🇸 Chicago, Illinois, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

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