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

Astute Medical, Inc.35 sites in 8 countries890 target enrollmentSeptember 2010

ConditionsAcute Kidney Injury

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Kidney Injury
Sponsor: Astute Medical, Inc.
Enrollment: 890
Locations: 35
Primary Endpoint: Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

February 2013

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Astute Medical, Inc.

Responsible Party

Sponsor

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.

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).