Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 3:59 AM
Study NCT ID:
NCT01209169
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2010-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 890}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2010-09-23', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.', 'timeFrame': '10/2010 to 2/2013', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kidney Renal'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '23388612', 'type': 'RESULT', '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.'}, {'pmid': '33566467', 'type': 'DERIVED', '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.'}, {'pmid': '31618746', 'type': 'DERIVED', '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.'}, {'pmid': '31240688', 'type': 'DERIVED', '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.'}, {'pmid': '25237065', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ICU patients at risk for AKI.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMales and females 21 years of age or older;\n\nSubjects 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:\n\n(Respiratory SOFA score of ≥ 2 (PaO2/FiO2 \\<300)and/or Cardiovascular SOFA score of ≥ 1 (MAP \\< 70 mm Hg and/or any vasopressor required).\n\nPatient (or authorized representative) able and willing to provide written informed consent for study participation.\n\nExclusion Criteria:\n\nSpecial 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."}, 'identificationModule': {'nctId': 'NCT01209169', 'briefTitle': 'Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astute Medical, Inc.'}, 'officialTitle': 'Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'Sapphire'}}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Maricopa Intergrated Health System', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92103-8781', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610-0254', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bruce W. Carter Department of Veterans Affairs Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Joseph M. Still Research Foundation, Inc.', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center Section of Nephrology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med. Center (BIDMC)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48374', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Providence Park Hospital', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New York Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'University Clinic for Internal Medicine', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '77000', 'city': 'Melun', 'country': 'France', 'facility': 'Marc Jacquet Hospital', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Haut-Lévéque Hospital', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '1090', 'city': 'Brussel', 'state': 'Belgium', 'country': 'Germany', 'facility': 'UZ Brussel'}, {'zip': '9000', 'city': 'Ghent', 'state': 'Belgium', 'country': 'Germany', 'facility': 'Ghent University Hospital'}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinik für Anästhesie, Intensivmedizin und Schmerztherapie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinik Frankfurt am Main', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '39120', 'city': 'Madgeburg', 'country': 'Germany', 'facility': 'Otto-von-Guericke-Universitat Magdeburg'}, {'zip': '08208', 'city': 'Sabadell', 'country': 'Spain', 'facility': 'Critical Care Center, Sabadell Hospital', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '17176', 'city': 'Solna', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': 'SE1 7EH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Guy's and St. Thomas Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'BN11 2DH', 'city': 'Worthing', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': 'Worthing Hospital', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}], 'overallOfficials': [{'name': 'John Kellum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Critical Care Medicine, University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astute Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}