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Clinical Trials/NCT02726958
NCT02726958CompletedNot Applicable

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

Centre Hospitalier Universitaire de Besancon1 site in 1 country160 target enrollmentStarted: March 2014Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guillaume BESCH

M.D.

Centre Hospitalier Universitaire de Besancon

Study Sites (1)

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