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

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ClinicalTrials.gov Identifier: NCT01209169
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Astute Medical, Inc.

Tracking Information
First Submitted Date September 23, 2010
First Posted Date September 27, 2010
Last Update Posted Date February 22, 2013
Study Start Date September 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 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).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
Official Title Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult ICU patients at risk for AKI.
Condition Acute Kidney Injury
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 16, 2012)
890
Original Estimated Enrollment
 (submitted: September 23, 2010)
250
Actual Study Completion Date February 2013
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Canada,   France,   Germany,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01209169
Other Study ID Numbers Sapphire
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Astute Medical, Inc.
Study Sponsor Astute Medical, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: John Kellum, MD Professor, Critical Care Medicine, University of Pittsburgh
PRS Account Astute Medical, Inc.
Verification Date February 2013