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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209169
• Other study ID #: Sapphire
• Status: Completed
• Phase: N/A
• First received: September 23, 2010
• Last updated: February 21, 2013
• Start date: September 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Astute Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 890
• Est. completion date: February 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
Austria	University Clinic for Internal Medicine	Innsbruck
Canada	University of Alberta	Edmonton	Alberta
France	Edouard Herriot Hospital	Lyon
France	Marc Jacquet Hospital	Melun
France	Haut-Lévéque Hospital	Pessac
Germany	Universitätsklinikum Aachen	Aachen
Germany	UZ Brussel	Brussel	Belgium
Germany	Klinik für Anästhesie, Intensivmedizin und Schmerztherapie	Frankfurt
Germany	Universitätsklinik Frankfurt am Main	Frankfurt
Germany	Ghent University Hospital	Ghent	Belgium
Germany	Otto-von-Guericke-Universitat Magdeburg	Madgeburg
Spain	Critical Care Center, Sabadell Hospital	Sabadell
Sweden	Karolinska University Hospital	Solna	Stockholm
United Kingdom	Guy's and St. Thomas Hospital	London	England
United Kingdom	King's College Hospital	London	England
United Kingdom	Worthing Hospital	Worthing	West Sussex
United States	Joseph M. Still Research Foundation, Inc.	Augusta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Med. Center (BIDMC)	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	New York Methodist Hospital	Brooklyn	New York
United States	University of Chicago Medical Center Section of Nephrology	Chicago	Illinois
United States	Durham VA Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	University of Louisville	Louisville	Kentucky
United States	Bruce W. Carter Department of Veterans Affairs Medical Center	Miami	Florida
United States	Providence Park Hospital	Novi	Michigan
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Maricopa Intergrated Health System	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Diego	San Diego	California
United States	Tampa General Hospital	Tampa	Florida
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Astute Medical, Inc.

Countries where clinical trial is conducted

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

References & Publications (1)

Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.	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).	10/2010 to 2/2013	No