Early Postoperative Blood Glucose Variability and Outcome After TAVI (GLYTAVI)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Stress Hyperglycemia

Study type: Observational

Funder types: Other

Identifiers

NCT02726958

EI/2014/141

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

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

group T

Description:

other patients