Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT01730820
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2012-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-12', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac output', 'timeFrame': 'one year', 'description': 'Comparing cardiac output values before and after injection of a phenylephrine bolus, based on the existence of a preload dependency, defined by a measure of respiratory variation of pulse pressure greater than or equal to 13%.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypotension']}, 'referencesModule': {'references': [{'pmid': '27164015', 'type': 'DERIVED', 'citation': 'Rebet O, Andremont O, Gerard JL, Fellahi JL, Hanouz JL, Fischer MO. Preload dependency determines the effects of phenylephrine on cardiac output in anaesthetised patients: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):638-44. doi: 10.1097/EJA.0000000000000470.'}]}, 'descriptionModule': {'briefSummary': 'The perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control.\n\nSeveral questions on phenylephrine global and regional hemodynamics effects remain unresolved.\n\nThe investigators assume that Phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. The investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.\n\nThe aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General anesthesia.Orotracheal intubation and mechanical ventilation Advanced Hemodynamic Monitoring intraoperative ( arterial pressure catheter, esophageal Doppler)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypotension (SBP \\<90 mm Hg and / or MAP \\<60 mm Hg)\n* Injection of a bolus of phenylephrine at the discretion of the anesthesiologist physician in charge of the patient.\n\nExclusion Criteria:\n\n* Minor or major patient under guardianship\n* Esophageal Diseases\n* supra ventricular rhythm trouble\n* Severe valvular\n* Shunt intracardiac\n* Vt \\<7ml/kg theoretical weight\n* heart rate / respiratory rate \\<3.6\n* Clinical hypepression of intra-abdominal\n* Compliance \\<30 mL/cmH2O\n* pulmonary hypertension, Right ventricular failure\n* Spontaneous Ventilation\n* Thorax open\n* VG severe dysfunction (LVEF \\<40%)\n* Prior Injection of ephedrine prior'}, 'identificationModule': {'nctId': 'NCT01730820', 'briefTitle': 'Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output', 'orgStudyIdInfo': {'id': 'NEO CO'}, 'secondaryIdInfos': [{'id': 'A12-D20-VOL12', 'type': 'OTHER', 'domain': 'Basse Normandie FRANCE ethics committee'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1400', 'city': 'Caen', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'CAEN University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Olivier REBET, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}