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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 Acute Kidney Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01209169
Enrollment
890
Registered
2010-09-27
Start date
2010-09-30
Completion date
2013-02-28
Last updated
2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Kidney Renal

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).

Interventions

None listed

Sponsors

Astute Medical, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.10/2010 to 2/2013Primary outcome measure: Identification and Validation of Biomarkers from Acutely ill patients at risk for AKI. (N=744) Secondary outcomes including follow-up (N=890).

Countries

Austria, Canada, France, Germany, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026