Early Postoperative Blood Glucose Variability and Outcome After TAVI

Centre Hospitalier Universitaire de Besancon160 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

160

Conditions

Stress Hyperglycemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU Jean Minjoz Besancon

Besançon, France

Outcomes

Primary Outcomes

Incidence of stress hyperglycemia

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.

Time frame: 48 hours

Secondary Outcomes

Mean blood glucose value

Mean blood glucose value is the mean of all the blood glucose values measured during the 48 first hours following the TAVI.

Time frame: 48 hours

Standard deviation of blood glucose value

Standard deviation of glucose value is the standard deviation of all the blood glucose values measured during the 48 first hours following the TAVI.

Time frame: 48 hours

Incidence of moderate hypoglycemia

Moderate hypoglycemia is defined as a blood glucose value under 3.3 mmol/l.

Time frame: 48 hours

Incidence of severe hypoglycemia

Severe hypoglycemia is defined as a blood glucose value under 2.2 mmol/l.

Time frame: 48 hours

Incidence of severe hyperglycemia

Severe hyperglycemia is defined as a blood glucose value above 11.0 mmol/l.

Time frame: 48 hours

Coefficient of variability of blood glucose

The coefficient of variability is the ratio of the standard deviation on the mean blood glucose value, expressed as a percentage.

Time frame: 48 hours

Mean daily variation of blood glucose

Data from ClinicalTrials.gov

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