Early Postoperative Blood Glucose Variability and Outcome After TAVI

Completed

• Conditions: Stress Hyperglycemia

• Registration Number: NCT02726958
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of stress hyperglycemia	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 Outcome Measures

Name	Time	Method
Standard deviation of blood glucose value	48 hours	Standard deviation of glucose value is the standard deviation of all the blood glucose values measured during the 48 first hours following the TAVI.
Incidence of moderate hypoglycemia	48 hours	Moderate hypoglycemia is defined as a blood glucose value under 3.3 mmol/l.
Mean blood glucose value	48 hours	Mean blood glucose value is the mean of all the blood glucose values measured during the 48 first hours following the TAVI.
Incidence of severe hypoglycemia	48 hours	Severe hypoglycemia is defined as a blood glucose value under 2.2 mmol/l.
Coefficient of variability of blood glucose	48 hours	The coefficient of variability is the ratio of the standard deviation on the mean blood glucose value, expressed as a percentage.
Incidence of severe hyperglycemia	48 hours	Severe hyperglycemia is defined as a blood glucose value above 11.0 mmol/l.
Mean daily variation of blood glucose	48 hours	The mean daily variation of blood glucose is defined as the mean of the daily differences between the maximal and the minimal glucose value.

Trial Locations

Locations (1)

CHRU Jean Minjoz Besancon; 🇫🇷 Besancon, France