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.|
|ClinicalTrials.gov Identifier: NCT01209169|
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : February 22, 2013
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Acute Kidney Injury|
|Study Type :||Observational|
|Actual Enrollment :||890 participants|
|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|
- 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).
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.
|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|
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.
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.
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 ClinicalTrials.gov identifier (NCT number): NCT01209169
|Principal Investigator:||John Kellum, MD||Professor, Critical Care Medicine, University of Pittsburgh|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Astute Medical, Inc.|
|Other Study ID Numbers:||
|First Posted:||September 27, 2010 Key Record Dates|
|Last Update Posted:||February 22, 2013|
|Last Verified:||February 2013|
Acute Kidney Injury
Wounds and Injuries