Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-04-17 @ 12:35 PM
Study NCT ID:
NCT02296866
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-26', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasonographic measurement of antral area', 'timeFrame': '30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion'}]}, 'conditionsModule': {'conditions': ['Emergency Surgery', 'Full Stomach']}, 'descriptionModule': {'briefSummary': 'The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all trauma patients with a full stomach, undegoing emergency surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency surgery for trauma\n* ASA 1 and 2 patients\n* Full stomach (antral area \\> 550 mm²)\n* Adult patients\n\nExclusion Criteria:\n\n* No contraindication to erythromycin\n* Extreme emergency surgery (time frame \\< 90 min between arrival in the service and the start of the surgery)\n* gastroparesis or pathology associated with gastroparesis'}, 'identificationModule': {'nctId': 'NCT02296866', 'briefTitle': 'Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Edouard Herriot'}, 'orgStudyIdInfo': {'id': '2013-A01257-38'}}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lionel Bouvet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Lionel Bouvet', 'investigatorAffiliation': 'Hôpital Edouard Herriot'}}}}