Clinical trial NCT01209169: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
Official title: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Kidney Renal
Lead sponsor: Astute Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 890
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients at risk for AKI.

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).


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.

Primary outcomes:
measure: Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.
timeFrame: 10/2010 to 2/2013
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Intergrated Health System
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Bruce W. Carter Department of Veterans Affairs Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Augusta
country: United States
facility: Joseph M. Still Research Foundation, Inc.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center Section of Nephrology
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Med. Center (BIDMC)
state: Massachusetts
city: Novi
country: United States
facility: Providence Park Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Innsbruck
country: Austria
facility: University Clinic for Internal Medicine
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Melun
country: France
facility: Marc Jacquet Hospital
city: Pessac
country: France
facility: Haut-Lévéque Hospital
city: Brussel
country: Germany
facility: UZ Brussel
state: Belgium
city: Ghent
country: Germany
facility: Ghent University Hospital
state: Belgium
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Frankfurt
country: Germany
facility: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie
city: Frankfurt
country: Germany
facility: Universitätsklinik Frankfurt am Main
city: Madgeburg
country: Germany
facility: Otto-von-Guericke-Universitat Magdeburg
city: Sabadell
country: Spain
facility: Critical Care Center, Sabadell Hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
state: Stockholm
city: London
country: United Kingdom
facility: Guy's and St. Thomas Hospital
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: West Sussex
Study officials:
affiliation: Professor, Critical Care Medicine, University of Pittsburgh
name: John Kellum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
citation: Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen HB, Rimmele T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators. Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi: 10.1097/CCM.0000000000004845.
citation: McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP, McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for Acute Kidney Injury over the Course of Critical Illness. Cardiorenal Med. 2019;9(6):358-369. doi: 10.1159/000502837. Epub 2019 Oct 16.
citation: Kane-Gill SL, Ostermann M, Shi J, Joyce EL, Kellum JA. Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin-Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study. Drug Saf. 2019 Oct;42(10):1149-1155. doi: 10.1007/s40264-019-00846-x.
citation: Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.