Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT01681758
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2012-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2012-09-06', 'studyFirstSubmitQcDate': '2012-09-07', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physiological outcome', 'timeFrame': '24 hours', 'description': 'cardiac index'}], 'primaryOutcomes': [{'measure': 'Mean amount of fluid given in the first 24 hours after surgery', 'timeFrame': '24 hours', 'description': 'all intravenous fluid administered'}], 'secondaryOutcomes': [{'measure': 'Physiological outcome', 'timeFrame': '24 hours', 'description': 'Blood lactate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'Pulse pressure variation', 'intravenous fluids'], 'conditions': ['Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '25220528', 'type': 'DERIVED', 'citation': 'Suzuki S, Woinarski NC, Lipcsey M, Candal CL, Schneider AG, Glassford NJ, Eastwood GM, Bellomo R. Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial. J Crit Care. 2014 Dec;29(6):992-6. doi: 10.1016/j.jcrc.2014.07.032. Epub 2014 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery', 'detailedDescription': '1. The investigators will study patients after cardiac surgery\n2. The investigators will collect data on standard care in pre-intervention population\n3. The investigators will collect demographic and clinical data\n4. The investigators will collect biochemical data in the first 24 hours after surgery\n5. The investigators will collect biochemical, physiological and clinical outcome data\n6. The investigators will compare the standard care and intervention period data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. immediately after ICU admission after cardiac surgery\n2. mandatory mechanical ventilation -\n\nExclusion Criteria:\n\n1. Pressure support ventilation\n2. ECMO\n3. Intra-aortic balloon counterpulsation'}, 'identificationModule': {'nctId': 'NCT01681758', 'briefTitle': 'An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Austin Health'}, 'officialTitle': 'A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'AICU2012-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PPV', 'description': 'use PPV to guide fluid therapy', 'interventionNames': ['Other: IV fluid according to PPV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'standard care', 'description': 'fluids according to standard care', 'interventionNames': ['Other: fluids according to standard care']}], 'interventions': [{'name': 'IV fluid according to PPV', 'type': 'OTHER', 'description': 'intravenous fluids', 'armGroupLabels': ['PPV']}, {'name': 'fluids according to standard care', 'type': 'OTHER', 'armGroupLabels': ['standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3079', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austin Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of ICU Research', 'investigatorFullName': 'Rinaldo Bellomo', 'investigatorAffiliation': 'Austin Health'}}}}