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

NCT01209169 | Completed

• 1 other identifier: Sapphire
• Study Type: observational
• Target: 890
• Locations: 8 countries
• Sites: 35

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).

Conditions

Acute Kidney Injury

Keywords

Kidney Renal

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients at risk for AKI.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astute Medical, Inc.: lead

Study Sites (35)

Maricopa Intergrated Health System

Phoenix, Arizona, 85008, United States

Location

University of California San Diego

San Diego, California, 92103-8781, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

University of Florida

Gainesville, Florida, 32610-0254, United States

Location

Bruce W. Carter Department of Veterans Affairs Medical Center

Miami, Florida, 33125, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Joseph M. Still Research Foundation, Inc.

Augusta, Georgia, 30909, United States

Location

University of Chicago Medical Center Section of Nephrology

Chicago, Illinois, 60637, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Med. Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

Providence Park Hospital

Novi, Michigan, 48374, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University Clinic for Internal Medicine

Innsbruck, 6020, Austria

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Edouard Herriot Hospital

Lyon, 69003, France

Location

Marc Jacquet Hospital

Melun, 77000, France

Location

Haut-Lévéque Hospital

Pessac, 33600, France

Location

UZ Brussel

Brussel, Belgium, 1090, Germany

Location

Ghent University Hospital

Ghent, Belgium, 9000, Germany

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Klinik für Anästhesie, Intensivmedizin und Schmerztherapie

Frankfurt, 60590, Germany

Location

Universitätsklinik Frankfurt am Main

Frankfurt, 60590, Germany

Location

Otto-von-Guericke-Universitat Magdeburg

Madgeburg, 39120, Germany

Location

Critical Care Center, Sabadell Hospital

Sabadell, 08208, Spain

Location

Karolinska University Hospital

Solna, Stockholm County, 17176, Sweden

Location

Guy's and St. Thomas Hospital

London, England, SE1 7EH, United Kingdom

Location

King's College Hospital

London, England, SE5 9RS, United Kingdom

Location

Worthing Hospital

Worthing, West Sussex, BN11 2DH, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 23388612 RESULT

• 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.

  PMID: 33566467 DERIVED

• 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.

  PMID: 31618746 DERIVED

• 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.

  PMID: 31240688 DERIVED

• 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.

  PMID: 25237065 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• John Kellum, MD

  Professor, Critical Care Medicine, University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 27, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

SE (1); AU (1); US (19); ES (1); CA (1); FR (3); GB (3); DE (6)