Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT01454258
Status:
COMPLETED
Last Update Posted:
2017-09-14
First Post:
2011-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Indication for Intraoperative Volume Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kai.zacharowski@kgu.de', 'phone': '004969630186668', 'title': 'Prof Dr Dr Kai Zacharowski, FRCA', 'organization': 'University Hospital Frankfurt'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cohort', 'description': 'Surgical patients', 'otherNumAtRisk': 10100, 'otherNumAffected': 0, 'seriousNumAtRisk': 10100, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Different Substitution Solutions Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9103', 'groupId': 'OG000'}, {'value': '9103', 'groupId': 'OG001'}, {'value': '9103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Crystalloids', 'description': 'crystalloids'}, {'id': 'OG001', 'title': 'Hydroxyethyl Starch', 'description': 'HES'}, {'id': 'OG002', 'title': 'Other Colloids', 'description': 'gelatine, albumin,'}], 'classes': [{'categories': [{'measurements': [{'value': '7827', 'groupId': 'OG000'}, {'value': '1055', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24h', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgical patients from 10 hospitals over a period of 13 months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort', 'description': 'Surgical patients from 10 hospitals over a period of 13 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '997'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort', 'description': 'Surgical patients from 10 hospitals over a period of 13 months'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Age data not collected.', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Gender data not collected.', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2011-10-14', 'resultsFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-05', 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Different Substitution Solutions Administered', 'timeFrame': '24h'}]}, 'conditionsModule': {'conditions': ['Patients Undergoing Any Kind of Surgery']}, 'descriptionModule': {'briefSummary': 'This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region). Furthermore the indication for usage of these solutions is investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of participating hospitals that will undergo surgery and receive intravenous fluid or volume treatment(cristalloid or colloid) will be included.\n\nParticipating hospitals are the university teaching hospitals of the Goethe University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing surgery receiving at least one bag of cristalloid or colloid solution\n\nExclusion Criteria:\n\n* decline of participation'}, 'identificationModule': {'nctId': 'NCT01454258', 'acronym': 'INDIZ_IV_I', 'briefTitle': 'Indication for Intraoperative Volume Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Indication for Intraoperative Volume Therapy', 'orgStudyIdInfo': {'id': 'INDIZ IV I'}}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Kai Zacharowski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Professor Kai Zacharowski, M.D., Ph.D., FRCA', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}