Clinical trial NCT02726958: Early Postoperative Blood Glucose Variability and Outcome After TAVI
Official title: Early Postoperative Blood Glucose Variability and Outcome After TAVI : a Retrospective Single-centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Hyperglycemia
Keywords: aortic valve replacement
percutaneous valve
blood glucose variability
TAVI
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Planned transcatheter aortic valve implantation

Brief summary: 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.

The 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.


Eligibility criteria: Inclusion Criteria:

* age\>18 years old
* severe degenerative symptomatic aortic stenosis
* logistic Euroscore ≥ 20% or/and Society of Thoracic Surgeons score (STS) ≥ 10%
* recused for a conventional valve replacement by multidisciplinary team (surgeon, cardiologist) because of surgical contraindication or comorbidities related to the patient.
* written consent before the procedure concerning anonymous data processing.

Exclusion Criteria:

* death per procedure
* postoperative admission in a critical care unit

Primary outcomes:
measure: Incidence of stress hyperglycemia
timeFrame: 48 hours
Secondary outcomes:
measure: Mean blood glucose value
timeFrame: 48 hours
measure: Standard deviation of blood glucose value
timeFrame: 48 hours
measure: Incidence of moderate hypoglycemia
timeFrame: 48 hours
measure: Incidence of severe hypoglycemia
timeFrame: 48 hours
measure: Incidence of severe hyperglycemia
timeFrame: 48 hours
measure: Coefficient of variability of blood glucose
timeFrame: 48 hours
measure: Mean daily variation of blood glucose
timeFrame: 48 hours
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU Jean Minjoz Besancon
Study officials:
affiliation: Centre hospitalier régional universitaire de Besançon
name: Sophie DEPIERRE
role: STUDY_CHAIR
References:
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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.
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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.