Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-30 @ 5:05 PM
Study NCT ID:
NCT01258361
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2010-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2010-12-10', 'studyFirstSubmitQcDate': '2010-12-10', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence / absence of a hypovolemia following preoperative fasting', 'timeFrame': '1 day', 'description': 'Hypovolemia is determined by the % change in the subaortic velocity time integral during a leg lift before and after fasting: a 15% decrease is considered as a "presence".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preoperative fasting'], 'conditions': ['Hypovolemia']}, 'referencesModule': {'references': [{'pmid': '24496782', 'type': 'RESULT', 'citation': 'Muller L, Briere M, Bastide S, Roger C, Zoric L, Seni G, de La Coussaye JE, Ripart J, Lefrant JY. Preoperative fasting does not affect haemodynamic status: a prospective, non-inferiority, echocardiography study. Br J Anaesth. 2014 May;112(5):835-41. doi: 10.1093/bja/aet478. Epub 2014 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited during anesthesia consultations carried out before programmed gynecological or visceral surgeries.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is ASA (American Society of Anesthesiologists) class I, II or III\n* The patient has not been fasting for more than 6 hours at the time of inclusion\n* The patient is schelduled for a gynecological or visceral surgery\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant\n* The patient is breastfeeding\n* The patient is ASA class IV\n* The patient has insulin dependent diabetes\n* The patient has a cardiac or respiratory dysfunction\n* The patient has a heart rhythm disorder\n* The patient has renal insufficiency with dialysis\n* The patient is being treated with diuretics\n* The patient has had a bowel preparation\n* Emergency surgery\n* Outpatient surgery'}, 'identificationModule': {'nctId': 'NCT01258361', 'briefTitle': 'Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting', 'orgStudyIdInfo': {'id': 'LOCAL/2010/LM-03'}, 'secondaryIdInfos': [{'id': '2010-A01275-34', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'The study population', 'description': 'Patients will be recruited during anesthesia consultations carried out before programmed pelvic or visceral surgeries.', 'interventionNames': ['Procedure: echocardiography']}], 'interventions': [{'name': 'echocardiography', 'type': 'PROCEDURE', 'description': 'Echocardiography is performed for all patients', 'armGroupLabels': ['The study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Laurent Muller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}