Early Postoperative Blood Glucose Variability and Outcome After TAVI

Early Postoperative Blood Glucose Variability and Outcome After TAVI : a Retrospective Single-centre Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02726958

Acronym

GLYTAVI

Enrollment

160

Registered

2016-04-04

Start date

2014-03-31

Completion date

2014-09-30

Last updated

2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Hyperglycemia

Keywords

aortic valve replacement, percutaneous valve, blood glucose variability, TAVI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
Incidence of severe hypoglycemia	48 hours	Severe hypoglycemia is defined as a blood glucose value under 2.2 mmol/l.
Incidence of severe hyperglycemia	48 hours	Severe hyperglycemia is defined as a blood glucose value above 11.0 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.
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.

Countries

France

Outcome results