Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-24 @ 8:21 AM
Study NCT ID:
NCT02726958
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Postoperative Blood Glucose Variability and Outcome After TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2016-04-01', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of stress hyperglycemia', 'timeFrame': '48 hours', 'description': 'Stress hyperglycemia is defined as a blood glucose value above 7.7 mmol/l requiring insulin infusion within the 48 first hours following the TAVI.'}], 'secondaryOutcomes': [{'measure': 'Mean blood glucose value', 'timeFrame': '48 hours', 'description': 'Mean blood glucose value is the mean of all the blood glucose values measured during the 48 first hours following the TAVI.'}, {'measure': 'Standard deviation of blood glucose value', 'timeFrame': '48 hours', 'description': 'Standard deviation of glucose value is the standard deviation of all the blood glucose values measured during the 48 first hours following the TAVI.'}, {'measure': 'Incidence of moderate hypoglycemia', 'timeFrame': '48 hours', 'description': 'Moderate hypoglycemia is defined as a blood glucose value under 3.3 mmol/l.'}, {'measure': 'Incidence of severe hypoglycemia', 'timeFrame': '48 hours', 'description': 'Severe hypoglycemia is defined as a blood glucose value under 2.2 mmol/l.'}, {'measure': 'Incidence of severe hyperglycemia', 'timeFrame': '48 hours', 'description': 'Severe hyperglycemia is defined as a blood glucose value above 11.0 mmol/l.'}, {'measure': 'Coefficient of variability of blood glucose', 'timeFrame': '48 hours', 'description': 'The coefficient of variability is the ratio of the standard deviation on the mean blood glucose value, expressed as a percentage.'}, {'measure': 'Mean daily variation of blood glucose', 'timeFrame': '48 hours', 'description': 'The mean daily variation of blood glucose is defined as the mean of the daily differences between the maximal and the minimal glucose value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aortic valve replacement', 'percutaneous valve', 'blood glucose variability', 'TAVI'], 'conditions': ['Stress Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '15650975', 'type': 'BACKGROUND', 'citation': 'Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7. doi: 10.1053/j.jvca.2004.08.003.'}, {'pmid': '20124887', 'type': 'BACKGROUND', 'citation': 'Meyfroidt G, Keenan DM, Wang X, Wouters PJ, Veldhuis JD, Van den Berghe G. Dynamic characteristics of blood glucose time series during the course of critical illness: effects of intensive insulin therapy and relative association with mortality. Crit Care Med. 2010 Apr;38(4):1021-9. doi: 10.1097/CCM.0b013e3181cf710e.'}, {'pmid': '18705566', 'type': 'BACKGROUND', 'citation': 'Dossett LA, Cao H, Mowery NT, Dortch MJ, Morris JM Jr, May AK. Blood glucose variability is associated with mortality in the surgical intensive care unit. Am Surg. 2008 Aug;74(8):679-85; discussion 685. doi: 10.1177/000313480807400802.'}, {'pmid': '19534781', 'type': 'BACKGROUND', 'citation': 'Bagshaw SM, Bellomo R, Jacka MJ, Egi M, Hart GK, George C; ANZICS CORE Management Committee. The impact of early hypoglycemia and blood glucose variability on outcome in critical illness. Crit Care. 2009;13(3):R91. doi: 10.1186/cc7921. Epub 2009 Jun 17.'}, {'pmid': '19435472', 'type': 'BACKGROUND', 'citation': 'Egi M, Bellomo R, Reade MC. Is reducing variability of blood glucose the real but hidden target of intensive insulin therapy? Crit Care. 2009;13(2):302. doi: 10.1186/cc7755. Epub 2009 Apr 6.'}, {'pmid': '22551129', 'type': 'BACKGROUND', 'citation': 'Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.'}, {'pmid': '20843959', 'type': 'BACKGROUND', 'citation': 'Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011 Jan;32(2):191-7. doi: 10.1093/eurheartj/ehq261. Epub 2010 Sep 15.'}, {'pmid': '30857532', 'type': 'DERIVED', 'citation': 'Besch G, Pili-Floury S, Morel C, Gilard M, Flicoteaux G, Salomon du Mont L, Perrotti A, Meneveau N, Chocron S, Schiele F, Le Breton H, Samain E, Chopard R. Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation: a post hoc cohort analysis. Cardiovasc Diabetol. 2019 Mar 11;18(1):27. doi: 10.1186/s12933-019-0831-3.'}]}, 'descriptionModule': {'briefSummary': 'Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in cardiac surgery. Recently, several authors have reported that increased blood glucose (BG) variability could worsen the prognosis in this population.The transcatheter aortic valve implantation (TAVI) is a low invasive procedure proposed as an alternative technique to aortic valve replacement surgery in high-risk patients.\n\nThe aim of this study is to describe the incidence of stress hyperglycaemia and assess whether BG variability could impact the outcome of patients undergoing TAVI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Planned transcatheter aortic valve implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years old\n* severe degenerative symptomatic aortic stenosis\n* logistic Euroscore ≥ 20% or/and Society of Thoracic Surgeons score (STS) ≥ 10%\n* recused for a conventional valve replacement by multidisciplinary team (surgeon, cardiologist) because of surgical contraindication or comorbidities related to the patient.\n* written consent before the procedure concerning anonymous data processing.\n\nExclusion Criteria:\n\n* death per procedure\n* postoperative admission in a critical care unit'}, 'identificationModule': {'nctId': 'NCT02726958', 'acronym': 'GLYTAVI', 'briefTitle': 'Early Postoperative Blood Glucose Variability and Outcome After TAVI', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Early Postoperative Blood Glucose Variability and Outcome After TAVI : a Retrospective Single-centre Study', 'orgStudyIdInfo': {'id': 'EI/2014/141'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group M', 'description': 'patients who died or suffered from stroke, acute coronary syndrome, heart failure, complete atrioventricular block or life-threatening ventricular arrhythmias within 30 days after the procedure'}, {'label': 'group T', 'description': 'other patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHRU Jean Minjoz Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Sophie DEPIERRE', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre hospitalier régional universitaire de Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Guillaume BESCH', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Besancon'}}}}