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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209169
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):
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).

Condition or disease
Acute Kidney Injury

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Study Type : Observational
Actual Enrollment : 890 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
Study Start Date : September 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI. [ Time Frame: 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult ICU patients at risk for AKI.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01209169

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Sponsors and Collaborators
Astute Medical, Inc.
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Principal Investigator: John Kellum, MD Professor, Critical Care Medicine, University of Pittsburgh
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Astute Medical, Inc. Identifier: NCT01209169    
Other Study ID Numbers: Sapphire
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013
Keywords provided by Astute Medical, Inc.:
Kidney Renal
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases