Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
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Purpose
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 |
|---|
|
Acute Kidney Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 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).
| Enrollment: | 890 |
| Study Start Date: | September 2010 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations
Show 35 Study Locations| Principal Investigator: | John Kellum, MD | Professor, Critical Care Medicine, University of Pittsburgh |
More Information
Publications:
| Responsible Party: | Astute Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01209169 History of Changes |
| Other Study ID Numbers: | Sapphire |
| Study First Received: | September 23, 2010 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Astute Medical, Inc.:
|
Kidney Renal |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013