Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery

NCT ID: NCT02407626

Last Updated: 2018-03-09

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

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-03-07

Brief Summary

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This study evaluates the myocardial protection against perioperative ischemia comparing two standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of the patients will receive volatile anesthesia while the other half will receive total intravenous anesthesia. Primary and secondary outcome parameters will be assessed after induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.

Detailed Description

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Volatile anaesthetics such as Sevoflurane have shown to have a protective effect regarding myocardial ischemia in the perioperative setting - the so-called "preconditioning". However the observed response of preconditioning in clinical trials is not consistent.

An increased perioperative insulin resistance especially in diabetic patients resulting in an increased postoperative morbidity and mortality may be responsible for these findings.

In an animal model, the use of propofol that is being routinely applied for general anesthesia was associated with a change of the insulin receptor substrate via phosphorylation and thus a change of insulin resistance.

Avoiding a total intravenous anesthesia and applying a volatile anesthesia may result in an increased cardioprotective effect by a reduction of the perioperative insulin resistance.

Conditions

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Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sevoflurane

Volatile anesthesia for elective cardiac surgery

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Volatile anesthesia is a clinical standard procedure

Propofol

Total intravenous anesthesia for elective cardiac surgery

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Total intravenous anesthesia is a clinical standard procedure

Interventions

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Propofol

Total intravenous anesthesia is a clinical standard procedure

Intervention Type DRUG

Sevoflurane

Volatile anesthesia is a clinical standard procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetes
* Elective cardiac surgery

Exclusion Criteria

* Emergency procedures
* Preop myocardial infarction
* Preop cardiac failure
* Preop renal replacement therapy
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

Triemli Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christoph K Hofer

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Zollinger, MD

Role: STUDY_CHAIR

Institute of Anesthesiology and Intensive Care Medicine Triemli City Hospital Zurich

Locations

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Triemli City Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Julier K, da Silva R, Garcia C, Bestmann L, Frascarolo P, Zollinger A, Chassot PG, Schmid ER, Turina MI, von Segesser LK, Pasch T, Spahn DR, Zaugg M. Preconditioning by sevoflurane decreases biochemical markers for myocardial and renal dysfunction in coronary artery bypass graft surgery: a double-blinded, placebo-controlled, multicenter study. Anesthesiology. 2003 Jun;98(6):1315-27. doi: 10.1097/00000542-200306000-00004.

Reference Type BACKGROUND
PMID: 12766638 (View on PubMed)

Lucchinetti E, Hofer C, Bestmann L, Hersberger M, Feng J, Zhu M, Furrer L, Schaub MC, Tavakoli R, Genoni M, Zollinger A, Zaugg M. Gene regulatory control of myocardial energy metabolism predicts postoperative cardiac function in patients undergoing off-pump coronary artery bypass graft surgery: inhalational versus intravenous anesthetics. Anesthesiology. 2007 Mar;106(3):444-57. doi: 10.1097/00000542-200703000-00008.

Reference Type BACKGROUND
PMID: 17325502 (View on PubMed)

Piriou V, Mantz J, Goldfarb G, Kitakaze M, Chiari P, Paquin S, Cornu C, Lecharny JB, Aussage P, Vicaut E, Pons A, Lehot JJ. Sevoflurane preconditioning at 1 MAC only provides limited protection in patients undergoing coronary artery bypass surgery: a randomized bi-centre trial. Br J Anaesth. 2007 Nov;99(5):624-31. doi: 10.1093/bja/aem264. Epub 2007 Oct 3.

Reference Type BACKGROUND
PMID: 17913754 (View on PubMed)

Zaugg M, Lucchinetti E, Uecker M, Pasch T, Schaub MC. Anaesthetics and cardiac preconditioning. Part I. Signalling and cytoprotective mechanisms. Br J Anaesth. 2003 Oct;91(4):551-65. doi: 10.1093/bja/aeg205.

Reference Type BACKGROUND
PMID: 14504159 (View on PubMed)

Zaugg M, Lucchinetti E, Garcia C, Pasch T, Spahn DR, Schaub MC. Anaesthetics and cardiac preconditioning. Part II. Clinical implications. Br J Anaesth. 2003 Oct;91(4):566-76. doi: 10.1093/bja/aeg206.

Reference Type BACKGROUND
PMID: 14504160 (View on PubMed)

Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.

Reference Type BACKGROUND
PMID: 17707752 (View on PubMed)

Lou PH, Lucchinetti E, Zhang L, Affolter A, Gandhi M, Zhakupova A, Hersberger M, Hornemann T, Clanachan AS, Zaugg M. Propofol (Diprivan(R)) and Intralipid(R) exacerbate insulin resistance in type-2 diabetic hearts by impairing GLUT4 trafficking. Anesth Analg. 2015 Feb;120(2):329-40. doi: 10.1213/ANE.0000000000000558.

Reference Type BACKGROUND
PMID: 25437926 (View on PubMed)

Whittington RA, Virag L, Marcouiller F, Papon MA, El Khoury NB, Julien C, Morin F, Emala CW, Planel E. Propofol directly increases tau phosphorylation. PLoS One. 2011 Jan 31;6(1):e16648. doi: 10.1371/journal.pone.0016648.

Reference Type BACKGROUND
PMID: 21304998 (View on PubMed)

Swart MJ, De Jager WH, Kemp JT, Nel PJ, Van Staden SL, Joubert G. The effect of the metabolic syndrome on the risk and outcome of coronary artery bypass graft surgery. Cardiovasc J Afr. 2012 Aug;23(7):400-4. doi: 10.5830/CVJA-2012-055.

Reference Type BACKGROUND
PMID: 22914999 (View on PubMed)

Wang L, Ko KW, Lucchinetti E, Zhang L, Troxler H, Hersberger M, Omar MA, Posse de Chaves EI, Lopaschuk GD, Clanachan AS, Zaugg M. Metabolic profiling of hearts exposed to sevoflurane and propofol reveals distinct regulation of fatty acid and glucose oxidation: CD36 and pyruvate dehydrogenase as key regulators in anesthetic-induced fuel shift. Anesthesiology. 2010 Sep;113(3):541-51. doi: 10.1097/ALN.0b013e3181e2c1a1.

Reference Type BACKGROUND
PMID: 20683255 (View on PubMed)

Other Identifiers

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STZ-IFA-0115

Identifier Type: -

Identifier Source: org_study_id

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