Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT03727503
Status:
TERMINATED
Last Update Posted:
2020-01-29
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Agreement and precision between two methods to measure pulse pressure variation (PPV)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Logisitic problem', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPV measure', 'timeFrame': 'baseline', 'description': 'PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)'}, {'measure': 'PPV measure', 'timeFrame': '1 minute after the end of volume expansion', 'description': 'PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the ability of a new smartphone PPV app to predict fluid responsiveness in cardiac surgical patients in the Intensive care unit (in the postoperative period)', 'detailedDescription': 'Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the ICU in ventilated and sedated patients. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional often costly devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults patients ( \\>18 years)\n* Patients scheduled for cardiac surgery\n* equipped with a femoral arterial catheter and the PICCO device\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* severe cardiac dysfunction'}, 'identificationModule': {'nctId': 'NCT03727503', 'acronym': 'Capstesia', 'briefTitle': 'Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Ability of a New PPV Smartphone Application to Predict Fluid Responsiveness in Cardiac Surgical Patients in the ICU', 'orgStudyIdInfo': {'id': 'P2018/487'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group/cohort', 'description': 'operated patients from cardiac surgery. Once they arrived in the ICU, we will measure PPV with the capstesia and the PICCO device at baseline, and after a volume expansion of 500 ml of crystalloid.', 'interventionNames': ['Other: PPV from the capstesia']}], 'interventions': [{'name': 'PPV from the capstesia', 'type': 'OTHER', 'description': 'we will challenge the application by doing 2 maneuvers: the first one is to increase the PEEP level from 5 to 15 cmH2O and the second one is the infusion of a mini-fluid challenge (100 ml) followed by the other 400 ml.', 'armGroupLabels': ['group/cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Alexandre Joosten, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ERASME'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexandre Joosten, MD PhD', 'investigatorAffiliation': 'Erasme University Hospital'}}}}