Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-02 @ 10:18 PM
Study NCT ID:
NCT03553459
Status:
UNKNOWN
Last Update Posted:
2019-10-08
First Post:
2018-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trendelenburg Maneuver Predicts Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation (TEMPLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-04', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'responders', 'timeFrame': 'within 1 minute after volume expansion', 'description': 'responders are defined by stroke volume increases over 15% after volume expansion of 500ml crystalloid'}, {'measure': 'nonresponders', 'timeFrame': 'within 1 minute after volume expansion', 'description': 'nonresponders are defined by stroke volume increases less than 15% after volume expansion of 500ml crystalloid'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fluid responsiveness', 'trendelenburg', 'extracorporeal membrane oxygenation'], 'conditions': ['Extracorporeal Membrane Oxygenation']}, 'referencesModule': {'references': [{'pmid': '33496906', 'type': 'DERIVED', 'citation': 'Luo JC, Su Y, Dong LL, Hou JY, Li X, Zhang Y, Ma GG, Zheng JL, Hao GW, Wang H, Zhang YJ, Luo Z, Tu GW. Trendelenburg maneuver predicts fluid responsiveness in patients on veno-arterial extracorporeal membrane oxygenation. Ann Intensive Care. 2021 Jan 26;11(1):16. doi: 10.1186/s13613-021-00811-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to verify the efficacy of using trendelenburg maneuver to predict fluid responsiveness in patients with extracorporeal membrane oxygenation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with ECMO and mechanical ventilator support\n* hypotension (MAP\\<65mmHg)\n* required volume expansion by clinical judgement of the intensivists\n\nExclusion Criteria:\n\n* severe hypotension with high dose of vasopressors\n* severe valve regurgitation\n* cardiac arrhythmia'}, 'identificationModule': {'nctId': 'NCT03553459', 'briefTitle': 'Trendelenburg Maneuver Predicts Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation (TEMPLE)', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Hemodynamic Changes Induced by Trendelenburg Maneuver to Predict Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation', 'orgStudyIdInfo': {'id': 'TEMPLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trendelenburg Maneuver', 'description': 'Trendelenburg maneuver is performed to predict fluid responsiveness. Responders are defined by an increase in stroke volume over 15% after infusion of 500ml of crystalloid solution.', 'interventionNames': ['Diagnostic Test: Trendelenburg Maneuver']}], 'interventions': [{'name': 'Trendelenburg Maneuver', 'type': 'DIAGNOSTIC_TEST', 'description': 'In the Trendelenburg position, the body is laid supine, or flat on the back with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.', 'armGroupLabels': ['Trendelenburg Maneuver']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhe Luo, Docttor', 'role': 'CONTACT', 'email': 'luo.zhe@zs-hospital.sh.cn', 'phone': '86-021-64041990'}], 'facility': 'Zhongshan hospital, Fudan university', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Guo-wei Tu, Doctor', 'role': 'CONTACT', 'email': 'tu.guowei@zs-hospital.sh.cn', 'phone': '86-021-64041990'}], 'overallOfficials': [{'name': 'Zhe Luo, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}