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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astute Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01209169
First received: September 23, 2010
Last updated: February 21, 2013
Last verified: February 2013
  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

Further study details as provided by Astute Medical, Inc.:

Primary Outcome Measures:
  • 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
Study Population

Adult ICU patients at risk for AKI.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209169

  Show 35 Study Locations
Sponsors and Collaborators
Astute Medical, Inc.
Investigators
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 September 30, 2014