Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-08 @ 1:47 AM
Study NCT ID:
NCT03780660
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the area under the ROC curve of the "CVPV-st" parameter', 'timeFrame': 'an average 60 - 90 minute during the procedure', 'description': 'Diagnostic accuracy of the CVPV during a standardized inspiratory maneuver (CVPV-st) to predict fluid responsiveness.'}], 'secondaryOutcomes': [{'measure': 'the area under the ROC curve of the "CVPV-un" parameter', 'timeFrame': 'an average 60 - 90 minute during the procedure', 'description': 'Diagnostic accuracy of the CVPV during an unstandardized inspiratory maneuver (CVPV-un) to predict fluid responsiveness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Volume expansion', 'fluid responsiveness', 'critically ill patient', 'spontaneously breathing patient', 'central venous pressure variation'], 'conditions': ['Breathing']}, 'referencesModule': {'references': [{'pmid': '37548683', 'type': 'RESULT', 'citation': 'Bourel C, Durand A, Ter Schiphorst B, Martin C, Onimus T, De Jonckheere J, Howsam M, Pierre A, Favory R, Preau S. RESPIRATION-RELATED VARIATIONS IN CENTRAL VENOUS PRESSURE AS PREDICTORS OF FLUID RESPONSIVENESS IN SPONTANEOUSLY BREATHING PATIENTS. Shock. 2023 Aug 1;60(2):190-198. doi: 10.1097/SHK.0000000000002164. Epub 2023 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients.\n\nCentral venous pressure (CVP) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient hospitalized in one of intensive care unit of Roger Salengro university hospital CHU Lille', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Spontaneous breathing without mechanical assistance\n* Central venous catheter (superior vena cava) and monitoring of central venous pressure\n* Urinary catheter and monitoring of intra-abdominal pressure\n\nExclusion Criteria:\n\n* Intolerance to ventilatory manœuvre including Severe basal dyspnea/Symptomatic heart failure (pulmonary edema)\n* Contraindication to passive leg raising (intracranial hypertension)\n* Passive leg raising unsuitable for measuring hemodynamic response : High grade aortic insufficiency/ Poor echogenicity unsuitable to measure the velocity-time /integral of aortic blood flow/ Pregnancy/Abdominal hypertension with abdominal compartment syndrome/ Lower leg amputation\n* Necessity of urgent hemodynamic therapy (within 90 min)\n* Modification of hemodynamic therapy during study protocol (vascular filling, increase catecholamine dose'}, 'identificationModule': {'nctId': 'NCT03780660', 'acronym': 'VPVC', 'briefTitle': 'Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients', 'orgStudyIdInfo': {'id': '2017_60'}, 'secondaryIdInfos': [{'id': '2018-A01449-46', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Sébastien Preau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}