Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT03830450
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2019-02-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers of Acute Kidney Injury in Cardiac Surgery
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': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2019-02-02', 'studyFirstSubmitQcDate': '2019-02-02', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)', 'timeFrame': 'One year', 'description': 'By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI'}, {'measure': 'Consecutive values of growth differentiation factor 15 (GDF-15)', 'timeFrame': 'One year', 'description': 'By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI'}, {'measure': 'Consecutive values of glomerular filtration rate (GFR)', 'timeFrame': 'One Year', 'description': 'By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney injury', 'Cardiac surgery', 'NGAL', 'GDF-15'], 'conditions': ['Acute Kidney Injury (Nontraumatic)']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)\n* older than 18 years\n\nExclusion Criteria:\n\n* previous known renal disease\n* patients on chronic dialysis'}, 'identificationModule': {'nctId': 'NCT03830450', 'acronym': 'AKIrisk', 'briefTitle': 'Biomarkers of Acute Kidney Injury in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Dubrava'}, 'officialTitle': 'Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'University North'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nikola Bradic, MD', 'role': 'CONTACT', 'email': 'nbradic@kbd.hr', 'phone': '+385 91 589 3480'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nikola Bradic, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Senior Lecturer', 'investigatorFullName': 'Nikola Bradic, MD', 'investigatorAffiliation': 'University Hospital Dubrava'}}}}