Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-03-06 @ 8:46 AM
Study NCT ID:
NCT00306059
Status:
WITHDRAWN
Last Update Posted:
2022-12-20
First Post:
2006-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Goal Directed Therapy 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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigators decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2006-03-21', 'studyFirstSubmitQcDate': '2006-03-21', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observation of acute kidney injury', 'timeFrame': 'after 48 hours'}], 'secondaryOutcomes': [{'measure': 'Organ failure during first 48 hours and during stay on intensive care unit', 'timeFrame': 'after 48 hours'}, {'measure': 'Duration of stay on intensive care unit and in hospital', 'timeFrame': 't0'}, {'measure': 'Mortality during stay on intensive care unit', 'timeFrame': 'after 28 days, 60 days and during stay in hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Injury, Acute']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years old\n* occurence of the early phase of acute kidney injury\n* stay on intensive care unit\n\nExclusion Criteria:\n\n* chronic haemodialysis\n* not given informed consent'}, 'identificationModule': {'nctId': 'NCT00306059', 'briefTitle': 'Early Goal Directed Therapy for Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Early Goal Directed Therapy for Acute Kidney Injury', 'orgStudyIdInfo': {'id': '2006/096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients having acute kidney injury', 'interventionNames': ['Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury']}], 'interventions': [{'name': 'Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury', 'type': 'PROCEDURE', 'description': 'Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.', 'armGroupLabels': ['patients having acute kidney injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Eric Hoste, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}