Early Postoperative Blood Glucose Variability and Outcome After TAVI

NCT ID: NCT02726958

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Stress Hyperglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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group M

patients who died or suffered from stroke, acute coronary syndrome, heart failure, complete atrioventricular block or life-threatening ventricular arrhythmias within 30 days after the procedure

No interventions assigned to this group

group T

other patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Guillaume BESCH

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sophie DEPIERRE

Role: STUDY_CHAIR

Centre hospitalier régional universitaire de Besançon

Locations

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CHRU Jean Minjoz Besancon

Besançon, , France

Site Status

Countries

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France

References

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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. doi: 10.1053/j.jvca.2004.08.003.

Reference Type BACKGROUND
PMID: 15650975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20124887 (View on PubMed)

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. doi: 10.1177/000313480807400802.

Reference Type BACKGROUND
PMID: 18705566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19534781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19435472 (View on PubMed)

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, Carrie 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.

Reference Type BACKGROUND
PMID: 22551129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20843959 (View on PubMed)

Besch G, Pili-Floury S, Morel C, Gilard M, Flicoteaux G, Salomon du Mont L, Perrotti A, Meneveau N, Chocron S, Schiele F, Le Breton H, Samain E, Chopard R. Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation: a post hoc cohort analysis. Cardiovasc Diabetol. 2019 Mar 11;18(1):27. doi: 10.1186/s12933-019-0831-3.

Reference Type DERIVED
PMID: 30857532 (View on PubMed)

Other Identifiers

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EI/2014/141

Identifier Type: -

Identifier Source: org_study_id

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