Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-02-21 @ 4:12 PM
Study NCT ID:
NCT03791606
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2018-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI at Intensive Care Unit(PRECISE-ICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 755}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-20', 'studyFirstSubmitDate': '2018-12-31', 'studyFirstSubmitQcDate': '2018-12-31', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MACEs for long-term follow up', 'timeFrame': '1 year', 'description': 'mortality,stent restenosis, recurrent myocardial infarction, target vessel revascularization,stroke,bleeding,required renal replacement therapy'}], 'primaryOutcomes': [{'measure': 'CI-AKI', 'timeFrame': '1 year', 'description': 'an absolute SCr increase ≥0.3 mg/dL or a relative increase in SCr ≥50% within 48 hours of contrast medium exposure'}], 'secondaryOutcomes': [{'measure': 'in-hospital adverse events', 'timeFrame': '1 year', 'description': 'congestive heart failure \\[CHF\\], bleeding, stroke, reinfarction, stent thrombosis, required renal replacement therapy, length of hospital stay, hospital costs, and mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CIN']}, 'descriptionModule': {'briefSummary': 'A retrospective, observational study included all consecutively critically ill patients undergoing percutaneous coronary intervention(PCI) at intensive care unit (ICU) in Fujian Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in critically ill patients undergoing PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Critically ill patients undergoing PCI at ICU were enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill patients undergoing PCI at ICU\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* end-stage renal disease (eGFR \\<15 mL/min/1.73 m2)\n* long-term dialysis treatment\n* intravascular administration of contrast medium within the last 7 or 3 days postoperatively'}, 'identificationModule': {'nctId': 'NCT03791606', 'acronym': 'PRECISE-ICU', 'briefTitle': 'Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI at Intensive Care Unit(PRECISE-ICU)', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Risk Factors,PREvention and outComes for Contrast-Induced Acute Kidney Injury in patientS undErgoing Percutaneous Coronary Intervention at Intensive Care Unit：a Single-center Cohort Study(PRECISE-ICU)', 'orgStudyIdInfo': {'id': 'KLin'}}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Provincial', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiyang Lin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Fujian Provincial Hospital', 'investigatorFullName': 'Kaiyang Lin', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}