Early Postoperative Blood Glucose Variability and Outcome After TAVI : a Retrospective Single-centre Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Incidence of stress hyperglycemia
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of stress hyperglycemia
Time Frame: 48 hours
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.
Secondary Outcomes
- Standard deviation of blood glucose value(48 hours)
- Incidence of moderate hypoglycemia(48 hours)
- Mean blood glucose value(48 hours)
- Incidence of severe hypoglycemia(48 hours)
- Coefficient of variability of blood glucose(48 hours)
- Incidence of severe hyperglycemia(48 hours)
- Mean daily variation of blood glucose(48 hours)
Investigators
Guillaume BESCH
M.D.
Centre Hospitalier Universitaire de Besancon
