Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02521350
Status:
UNKNOWN
Last Update Posted:
2015-08-13
First Post:
2015-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Perioperative Acute Kidney Injury Incidence
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': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-10', 'studyFirstSubmitDate': '2015-06-18', 'studyFirstSubmitQcDate': '2015-08-10', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in serum creatinine levels at 24h after surgery', 'timeFrame': 'Serum creatinine levels will be measured at baseline and up to 24h after surgery', 'description': 'AKI incidence determination using 50 % or more than 0.3 mg/dL increment of creatinine levels'}, {'measure': 'Correlation with use of drugs before surgery and serum creatinine level at 24h after surgery', 'timeFrame': 'Use of drug before surgery and serum creatinine level at 24h after surgery will be correlated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Surgery', 'Perioperative care'], 'conditions': ['Intensive Care Unit Syndrome']}, 'referencesModule': {'references': [{'pmid': '23744003', 'type': 'RESULT', 'citation': 'Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. doi: 10.2215/CJN.00710113. Epub 2013 Jun 6.'}, {'pmid': '18160961', 'type': 'RESULT', 'citation': 'Ricci Z, Cruz D, Ronco C. The RIFLE criteria and mortality in acute kidney injury: A systematic review. Kidney Int. 2008 Mar;73(5):538-46. doi: 10.1038/sj.ki.5002743. Epub 2007 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'In the last few years, acute renal injury (AKI) definition has been significantly changed. In the light of the data obtained from multicenter international studies, acute renal injury was redefined according to RIFLE, AKIN and KDIGO criteria. The common criteria of all three criteria in acute renal failure is the increment of level of creatinine as 0.3 mg/dL or 50 % increment of respective basal value of serum creatinine.\n\nIn the current study, older than 40 years patients with no specific gender, who will stay at least one night in hospital will be included and cardiovascular and urological surgery patients and patients with known renal insufficiency will be excluded. It was aimed to measure serum creatinine levels in all included patients at baseline and up to 24h after surgery and will be determined acute kidney injury incidence and risk factors according to new criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'older than 40 years, no gender specified, patients who will stay at least one night in hospital except cardiovascular, urological surgery and known renal insufficiency.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 40 years\n* no gender specified\n* patients who will stay at least one night in hospital\n* patient with normal renal function\n\nExclusion Criteria:\n\n* patient with renal dysfunction and cardiovascular, urological surgery patients'}, 'identificationModule': {'nctId': 'NCT02521350', 'briefTitle': 'Determination of Perioperative Acute Kidney Injury Incidence', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Perioperative Acute Kidney Injury Incidence and Risk Factors in Non-cardiac Surgery', 'orgStudyIdInfo': {'id': 'ATADEK 2015-6 /19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': '\\- older than 40 years patients with no specific gender, who will stay at least one night in hospital will be included into our study. And cardiovascular, urological surgery patients and patients with known renal insufficiency will be excluded.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fevzi TORAMAN, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibadem University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kadikoy Hospital', 'class': 'OTHER'}, {'name': 'Acibadem Atakent University Hospital', 'class': 'OTHER'}, {'name': 'Acibadem Fulya Hospital', 'class': 'OTHER'}, {'name': 'Acibadem Ankara Hospital', 'class': 'OTHER'}, {'name': 'Acibadem Eskişehir Hastanesi', 'class': 'OTHER'}, {'name': 'Acibadem Bursa Hospital', 'class': 'OTHER'}, {'name': 'Kayseri Acibadem Hospital', 'class': 'UNKNOWN'}, {'name': 'Acıbadem Adana Hospital', 'class': 'OTHER'}, {'name': 'Acibadem Kozyatagi Hospital', 'class': 'OTHER'}, {'name': 'Acibadem Kocaeli Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}