Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT00855127
Status:
WITHDRAWN
Last Update Posted:
2015-06-01
First Post:
2009-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine supernatent Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2009-03-03', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of acute kidney injury as defined by a 50% increase in serum creatinine', 'timeFrame': 'Within 2 to 5 days of liver transplant that is sustained for at least 24 hours'}], 'secondaryOutcomes': [{'measure': 'Development of severe acute kidney injury, as defined as a doubling of serum creatinine', 'timeFrame': 'Within 2-5 days of transplant that is sustained for at least 24 hours'}, {'measure': 'The need for renal replacement therapy', 'timeFrame': 'After liver transplant operation to discharge'}, {'measure': 'All cause mortality', 'timeFrame': 'After liver transplant operation to discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biological Markers', 'Renal Replacement Therapy', 'Mortality'], 'conditions': ['Renal Insufficiency, Acute']}, 'referencesModule': {'references': [{'pmid': '18565474', 'type': 'BACKGROUND', 'citation': 'Edelstein CL. Biomarkers of acute kidney injury. Adv Chronic Kidney Dis. 2008 Jul;15(3):222-34. doi: 10.1053/j.ackd.2008.04.003.'}, {'pmid': '16710348', 'type': 'BACKGROUND', 'citation': 'Parikh CR, Mishra J, Thiessen-Philbrook H, Dursun B, Ma Q, Kelly C, Dent C, Devarajan P, Edelstein CL. Urinary IL-18 is an early predictive biomarker of acute kidney injury after cardiac surgery. Kidney Int. 2006 Jul;70(1):199-203. doi: 10.1038/sj.ki.5001527. Epub 2006 May 17.'}, {'pmid': '16148039', 'type': 'BACKGROUND', 'citation': 'Parikh CR, Abraham E, Ancukiewicz M, Edelstein CL. Urine IL-18 is an early diagnostic marker for acute kidney injury and predicts mortality in the intensive care unit. J Am Soc Nephrol. 2005 Oct;16(10):3046-52. doi: 10.1681/ASN.2005030236. Epub 2005 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.', 'detailedDescription': 'Patients with end stage liver disease that receive a liver transplant will be studied to determine if novel serum and urine biomarkers (serum cystatin C, urine interleukin-18 \\[IL-18\\] and urine neutrophil gelatinase associated lipocalin \\[NGAL\\]) can predict the outcome measures listed above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting to the University of Colorado Hospital or the University of Washington Medical Center for a liver transplant operation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First time liver transplant recipient\n* Cadaveric or living donor livers\n\nExclusion Criteria:\n\n* Unconscious patients or patients who cannot give consent\n* Pregnant women\n* Prisoners\n* Patients receiving dialysis before or during liver transplant operation\n* Patients receiving simultaneous liver-kidney transplants'}, 'identificationModule': {'nctId': 'NCT00855127', 'briefTitle': 'New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients', 'orgStudyIdInfo': {'id': '08-0769'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver transplant recipients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Angela M Walcher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Charles L Edelstein, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Connie L Davis, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Denver Health Medical Center', 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}