Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT03589261
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2018-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Flow ratio of portal flow on hepatic artery flow', 'timeFrame': 'Two hours', 'description': 'Flow ratio of portal flow on hepatic artery flow before and after a volume expansion of 500 ml NaCl 0.9%.'}], 'primaryOutcomes': [{'measure': 'Portal blood flow measure before and after fluid challenge', 'timeFrame': 'Two hours: the difference in hepatic portal flow before and after a volume expansion of 500 ml NaCl 0.9%.', 'description': 'Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI (magnetic resonance imaging).'}], 'secondaryOutcomes': [{'measure': 'Hepatic artery blood flow measure before and after fluid challenge', 'timeFrame': 'Two hours', 'description': 'Hepatic artery blood flow measure before and after a volume expansion of 500 ml NaCl 0.9%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Flow Changes']}, 'referencesModule': {'references': [{'pmid': '35574483', 'type': 'RESULT', 'citation': 'Abou-Arab O, Beyls C, Moussa MD, Huette P, Beaudelot E, Guilbart M, De Broca B, Yzet T, Dupont H, Bouzerar R, Mahjoub Y. Portal Vein Pulsatility Index as a Potential Risk of Venous Congestion Assessed by Magnetic Resonance Imaging: A Prospective Study on Healthy Volunteers. Front Physiol. 2022 Apr 29;13:811286. doi: 10.3389/fphys.2022.811286. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. During fluid challenge in intensive care unit, fluid challenge is often administered to improve hepatic perfusion. That observation is not demonstrated. The aim of the study is to test buffer response and portal flow during fluid challenge.', 'detailedDescription': 'Prospective monocentric study at Amiens Hospital University. 20 volunteers subjects will be include after providing informed consent. Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting for the last 12 hours.\n\nExclusion Criteria:\n\n* Claustrophobia\n* Any previous medical history disease;\n* Any abdominal surgical disease\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03589261', 'acronym': 'PORTEAU', 'briefTitle': 'Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects: a Prospective Monocentric Study. PORTEAU Trial', 'orgStudyIdInfo': {'id': 'PI2018_843_0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI (magnetic resonance imaging)', 'description': 'Hepatic blood flow baseline will be measured using MRI. Fluid challenge of 500 ml of NaCl 0.9% will be administered during 10 minutes. Before and After fluid challenge, MRI will be performed to compare flow changes.', 'interventionNames': ['Device: MRI (magnetic resonance imaging)']}], 'interventions': [{'name': 'MRI (magnetic resonance imaging)', 'type': 'DEVICE', 'otherNames': ['500 ml of intra venous NaCl (0.9%).'], 'description': 'Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.', 'armGroupLabels': ['MRI (magnetic resonance imaging)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}