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

NCT ID: NCT01209169

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 890 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astute Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Kellum, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, Critical Care Medicine, University of Pittsburgh

Locations

Maricopa Intergrated Health System

Phoenix, Arizona, United States

University of California San Diego

San Diego, California, United States

George Washington University

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

University of Florida

Gainesville, Florida, United States

Bruce W. Carter Department of Veterans Affairs Medical Center

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Joseph M. Still Research Foundation, Inc.

Augusta, Georgia, United States

University of Chicago Medical Center Section of Nephrology

Chicago, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Beth Israel Deaconess Med. Center (BIDMC)

Boston, Massachusetts, United States

Providence Park Hospital

Novi, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

New York Methodist Hospital

Brooklyn, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Durham VA Medical Center

Durham, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University Clinic for Internal Medicine

Innsbruck, , Austria

University of Alberta

Edmonton, Alberta, Canada

Edouard Herriot Hospital

Lyon, , France

Marc Jacquet Hospital

Melun, , France

Haut-Lévéque Hospital

Pessac, , France

UZ Brussel

Brussel, Belgium, Germany

Ghent University Hospital

Ghent, Belgium, Germany

Universitätsklinikum Aachen

Aachen, , Germany

Klinik für Anästhesie, Intensivmedizin und Schmerztherapie

Frankfurt, , Germany

Universitätsklinik Frankfurt am Main

Frankfurt, , Germany

Otto-von-Guericke-Universitat Magdeburg

Madgeburg, , Germany

Critical Care Center, Sabadell Hospital

Sabadell, , Spain

Karolinska University Hospital

Solna, Stockholm County, Sweden

Guy's and St. Thomas Hospital

London, England, United Kingdom

King's College Hospital

London, England, United Kingdom

Worthing Hospital

Worthing, West Sussex, United Kingdom

Countries

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

References

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.

Reference Type: RESULT

PMID: 23388612 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33566467 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31618746 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31240688 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25237065 (View on PubMed)

Other Identifiers

Sapphire

Identifier Type: -

Identifier Source: org_study_id