Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-17 @ 9:29 PM
Study NCT ID:
NCT03023618
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2017-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Oriented Therapy During Major Abdominal Surgery
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2017-01-01', 'studyFirstSubmitQcDate': '2017-01-17', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'amount of intraoperative fluids', 'timeFrame': 'an average of 12 hours'}], 'primaryOutcomes': [{'measure': 'complication rate', 'timeFrame': 'up to 30 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'an average of 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['[G09.330.380]'], 'conditions': ['Goal Directed Therapy']}, 'descriptionModule': {'briefSummary': 'In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-2 patients\n\nExclusion Criteria:\n\n* Severe Caridiac Disease\n* Renal Failure'}, 'identificationModule': {'nctId': 'NCT03023618', 'briefTitle': 'Fluid Oriented Therapy During Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery', 'orgStudyIdInfo': {'id': 'PERILLI-NICE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'patients before 2014, in which fluids were administered without FloTrac monitoring'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'case group', 'description': 'patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol)', 'interventionNames': ['Device: FloTrac']}], 'interventions': [{'name': 'FloTrac', 'type': 'DEVICE', 'description': 'Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011', 'armGroupLabels': ['case group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Valter MD Perilli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dr.Andrea Russo', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}