Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
Study NCT ID:
NCT01753050
Status:
UNKNOWN
Last Update Posted:
2019-07-24
First Post:
2012-12-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIP Surgery - Hemodynamic Optimization Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2012-12-17', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': '30days'}], 'secondaryOutcomes': [{'measure': 'length of hospital and ICU stay', 'timeFrame': '30days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Redo Hip Surgery']}, 'referencesModule': {'references': [{'pmid': '37024966', 'type': 'DERIVED', 'citation': 'Trauzeddel RF, Leitner M, Dehe L, Nordine M, Piper SK, Habicher M, Sander M, Perka C, Treskatsch S. Goal-directed fluid therapy using uncalibrated pulse contour analysis and balanced crystalloid solutions during hip revision arthroplasty: a quality implementation project. J Orthop Surg Res. 2023 Apr 6;18(1):281. doi: 10.1186/s13018-023-03738-0.'}, {'pmid': '27999663', 'type': 'DERIVED', 'citation': 'Habicher M, Balzer F, Mezger V, Niclas J, Muller M, Perka C, Kramer M, Sander M. Implementation of goal-directed fluid therapy during hip revision arthroplasty: a matched cohort study. Perioper Med (Lond). 2016 Dec 13;5:31. doi: 10.1186/s13741-016-0056-x. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Several studies have demonstrated that goal-directed fluid therapy during high- risk-surgery reduces morbidity and length of hospital stay. This quality improvement is design to evaluate the implementation of an intraoperative goal-directed therapy, using a pulse contour analysis monitor to optimize the stroke volume, in patients undergoing redo-hip-surgery. The primary combined endpoints will be the incidence of postoperative complications and the secondary endpoints will be the decrease of hospital length of stay, length of ICU stay and hospital postoperative mortality. We amended another 130 patients getting crystalloid fluids in the hemodynamic optimization protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing redo hip surgery\n* age above 18 years\n* signed informed consent\n\nExclusion Criteria:\n\n* urgent or emergency surgery'}, 'identificationModule': {'nctId': 'NCT01753050', 'acronym': 'HipHop', 'briefTitle': 'HIP Surgery - Hemodynamic Optimization Project', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'A Quality Improvement Project for Goal-directed Intraoperative Hemodynamic Optimization in Patients Redo Hip Surgery', 'orgStudyIdInfo': {'id': 'HipHop'}, 'secondaryIdInfos': [{'id': 'EA1/315/12', 'type': 'OTHER', 'domain': 'ethics commitee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'No specific hemodynamic optimization measures'}, {'type': 'EXPERIMENTAL', 'label': 'Hemodynamic optimization', 'description': 'Hemodynamic optimization by stroke volume monitoring', 'interventionNames': ['Device: Stroke volume monitoring']}], 'interventions': [{'name': 'Stroke volume monitoring', 'type': 'DEVICE', 'description': 'Pulse contour stroke volume monitoring', 'armGroupLabels': ['Hemodynamic optimization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Sascha Treskatsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Sascha Treskatsch', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}