Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT02296593
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples for determination of lactate and glucose blood levels'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of absolute blood lactate and glucose levels with the reference method (co oxymetry) and a new method using a device providing real time measures of lactate and glycemia with a central veinous catheter microdialysis system.', 'timeFrame': '1 day', 'description': 'Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)'}], 'secondaryOutcomes': [{'measure': 'comparison of variations of blood lactate and glycemia levels with the reference method (co oxymetry) and a new method using a device providing real time measures of lactate and glycemia. (EIRUS) with a central veinous catheter microdialysis system.', 'timeFrame': '1 day', 'description': 'Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lactate', 'continuous lactate monitoring', 'continuous blood glucose monitoring', 'EIRUS', 'blood glucose', 'cardiac surgery', 'central veinous catheter', 'microdialysis'], 'conditions': ['Other Functional Disturbances Following Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '29028910', 'type': 'DERIVED', 'citation': 'Gouezel C, Lorne E, Bonnet V, Fradin S, Saplacan V, Gerard JL, Hanouz JL, Fellahi JL, Fischer MO; FHT (French Hemodynamic Team). Assessment of changes in lactate concentration with intravascular microdialysis during high-risk cardiac surgery using the trend interchangeability method. Br J Anaesth. 2017 Dec 1;119(6):1110-1117. doi: 10.1093/bja/aex338.'}]}, 'descriptionModule': {'briefSummary': 'Continuous lactate and glucose blood levels', 'detailedDescription': 'MAQUET Group offers a new device that gives real time blood lactate and glucose levels. It is a new central veinous catheter with a microdialysis system. It is planted in the superior vena cava. It has not yet been used and validated with a clinical purpose, and particularly in cardiac surgery.\n\nFor now, reference method for determining blood lactate and glucose levels is co oxymetry.\n\nThis new simple device could provide great fluency for determining blood lactate and glucose levels. It could allow medical teams gain time for diagnosis and treatment of both hyperlactatemia and hyperglycemia.\n\nThe primary outcome of this study was to compare blood lactate and glucose absolute measures provided with the MAQUET new device (Maquet Critical Care AB, Solna, Sweden) and with co oxymetry.\n\nThe secondary outcome of this study was to compare variations of these absolutes measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients of cardiac surgery. (planned or for emergencies)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women more than 18 years old.\n* Cardiac surgery.\n* Central veinous catheter in superior vena cava.\n\nExclusion Criteria:\n\n* Men or women less than 18 years old.\n* Pregnant women.\n* Central veinous catheter not in superior vena cava.'}, 'identificationModule': {'nctId': 'NCT02296593', 'acronym': 'MONILAG', 'briefTitle': 'Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.', 'orgStudyIdInfo': {'id': 'A14-D36-VOL.22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'comparison of blood lactate and glucose levels', 'type': 'DEVICE', 'otherNames': ['EIRUS', 'continuous lactate monitoring', 'continuous glycemia monitoring', 'central veinous catheter', 'microdialysis system', 'MAQUET'], 'description': 'comparison of blood lactate and glucose levels with the reference method (co oxymetry) and a new central veinous catheter microdialysis system provided by MAQUET. (Critical Care AB, Solna, Sweden.)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}