AzTrials
AzTrials

Myocardial IschemiaOPTNCT02407626

Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery

A study testing Propofol and Sevoflurane in people with Myocardial Ischemia, run by Triemli Hospital at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 85 years, men only
Conditions the study is for
Myocardial Ischemia
What is being tested?
Propofol and Sevoflurane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteSwitzerland
Study dates
Sep 2015to 7 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetes
  • Elective cardiac surgery

Who cannot join

  • Emergency procedures
  • Preop myocardial infarction
  • Preop cardiac failure
  • Preop renal replacement therapy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Triemli City Hospital

    Zurich, 8063

Other trials in Switzerland

About this study

Official title: Optimierung Der Kardioprotektion Durch Inhalative Anästhetika Eine Untersuchung Bei Patienten Mit Diabetes Mellitus während Off-pump Herzchirurgie

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.

Read the detailed description

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.

Being tested
Propofol, Sevoflurane
Keywords
ischemia, cardiac surgery, volatile anesthetic, total intravenous anesthesia
Medical subject headings
Myocardial Ischemia, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    Total intravenous anesthesia is a clinical standard procedure

  • SevofluraneDrug

    Volatile anesthesia is a clinical standard procedure

Study groups in NCT02407626
Study groupRoleWhat they receive
SevofluraneExperimentalVolatile anesthesia for elective cardiac surgery
Receives: Drug: Sevoflurane
PropofolActive comparatorTotal intravenous anesthesia for elective cardiac surgery
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biomarker NT-proBNP

    Difference between volatile anesthesia and total intravenous anesthesia

    Measured: 1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3

Secondary outcomes (2)

  1. Receptor Substrate phosphorylization (IRS-1)/PP2A

    Difference between volatile anesthesia and total intravenous anesthesia

    Measured: 1. beginning of cardiac surgery, 2. end of cardiac surgery

  2. Expression of TNF/IL1beta and microRNA (miR144, miR125b, miR208a)

    Difference between volatile anesthesia and total intravenous anesthesia

    Measured: 1. beginning of cardiac surgery, 2. end of cardiac surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion7 Mar 2018
  4. Study completion7 Mar 2018

Why it stopped: Very low patient recruitment, changed insurance requirements

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407626
Sponsor's protocol ID
STZ-IFA-0115
Acronym
OPT
Status last verified
Mar 2018
First submitted
18 Mar 2015
Last updated
9 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12766638

  • 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.

    PubMed 17325502

  • 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.

    PubMed 17913754

  • 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.

    PubMed 14504159

  • 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.

    PubMed 14504160

  • 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.

    PubMed 17707752

  • 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.

    PubMed 25437926

  • 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.

    PubMed 21304998

  • 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.

    PubMed 22914999

  • 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.

    PubMed 20683255

Questions about this trial

What is this clinical trial studying?

A study testing Propofol and Sevoflurane in people with Myocardial Ischemia, run by Triemli Hospital at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Very low patient recruitment, changed insurance requirements). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomarker NT-proBNP (time frame: 1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02407626, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.

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