Early Postoperative Blood Glucose Variability and Outcome After TAVI

Stress Hyperglycemia Clinical Trial

— GLYTAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726958
• Other study ID #: EI/2014/141
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: August 31, 2017
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Stress Hyperglycemia

Locations

Country	Name	City	State
France	CHRU Jean Minjoz Besancon	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (7)

Bagshaw SM, Bellomo R, Jacka MJ, Egi M, Hart GK, George C; ANZICS CORE Management Committee. The impact of early hypoglycemia and blood glucose variability on outcome in critical illness. Crit Care. 2009;13(3):R91. doi: 10.1186/cc7921. Epub 2009 Jun 17. — View Citation

Dossett LA, Cao H, Mowery NT, Dortch MJ, Morris JM Jr, May AK. Blood glucose variability is associated with mortality in the surgical intensive care unit. Am Surg. 2008 Aug;74(8):679-85; discussion 685. — View Citation

Egi M, Bellomo R, Reade MC. Is reducing variability of blood glucose the real but hidden target of intensive insulin therapy? Crit Care. 2009;13(2):302. doi: 10.1186/cc7755. Epub 2009 Apr 6. — View Citation

Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011 Jan;32(2):191-7. doi: 10.1093/eurheartj/ehq261. Epub 2010 Sep 15. — View Citation

Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705. — View Citation

Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7. — View Citation

Meyfroidt G, Keenan DM, Wang X, Wouters PJ, Veldhuis JD, Van den Berghe G. Dynamic characteristics of blood glucose time series during the course of critical illness: effects of intensive insulin therapy and relative association with mortality. Crit Care Med. 2010 Apr;38(4):1021-9. doi: 10.1097/CCM.0b013e3181cf710e. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours
Secondary	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.	48 hours
Secondary	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.	48 hours
Secondary	Incidence of moderate hypoglycemia	Moderate hypoglycemia is defined as a blood glucose value under 3.3 mmol/l.	48 hours
Secondary	Incidence of severe hypoglycemia	Severe hypoglycemia is defined as a blood glucose value under 2.2 mmol/l.	48 hours
Secondary	Incidence of severe hyperglycemia	Severe hyperglycemia is defined as a blood glucose value above 11.0 mmol/l.	48 hours
Secondary	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.	48 hours
Secondary	Mean daily variation of blood glucose	The mean daily variation of blood glucose is defined as the mean of the daily differences between the maximal and the minimal glucose value.	48 hours