NCT01209169CompletedNot Applicable
Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
Astute Medical, Inc.35 sites in 8 countries890 target enrollmentStarted: September 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Astute Medical, Inc.
- Enrollment
- 890
- Locations
- 35
- Primary Endpoint
- Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (35)
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