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NCT Number: NCT02726958

Early Postoperative Blood Glucose Variability and Outcome After TAVI

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.

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Key information

Conditions

Stress Hyperglycemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Jean Minjoz Besancon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Mean blood glucose value

    Time frame: 48 hours

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

  2. Standard deviation of blood glucose value

    Time frame: 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.

  3. Incidence of moderate hypoglycemia

    Time frame: 48 hours

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

  4. Incidence of severe hypoglycemia

    Time frame: 48 hours

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

  5. Incidence of severe hyperglycemia

    Time frame: 48 hours

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

  6. Coefficient of variability of blood glucose

    Time frame: 48 hours

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

  7. Mean daily variation of blood glucose

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: GLYTAVI

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2016
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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