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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astute Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01209169
First received: September 23, 2010
Last updated: February 21, 2013
Last verified: February 2013

September 23, 2010
February 21, 2013
September 2010
April 2012   (final data collection date for primary outcome measure)
Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI. [ Time Frame: 10/2010 to 2/2013 ] [ Designated as safety issue: No ]
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).
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Complete list of historical versions of study NCT01209169 on ClinicalTrials.gov Archive Site
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Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Adult ICU patients at risk for AKI.

Acute Kidney Injury
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Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
890
February 2013
April 2012   (final data collection date for primary outcome measure)

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.

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   France,   Germany,   Spain,   Sweden,   United Kingdom
 
NCT01209169
Sapphire
No
Astute Medical, Inc.
Astute Medical, Inc.
Not Provided
Principal Investigator: John Kellum, MD Professor, Critical Care Medicine, University of Pittsburgh
Astute Medical, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP