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Volatile Anesthetics to Reduce Mortality in Cardiac Surgery (MYRIAD)

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ClinicalTrials.gov Identifier: NCT02105610
Recruitment Status : Recruiting
First Posted : April 7, 2014
Last Update Posted : June 28, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

There is initial evidence that the choice of anesthesia can influence survival in the specific setting of coronary artery bypass grafting surgery (CABG).

A recent international consensus conference included volatile agents among the few drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin release and mortality in patients receiving volatile anesthetics when compared to patients receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can translate into a reduced mortality rate in patients receiving volatile agents. The level of evidence for these four studies is not high (one meta-regression, one underpowered randomized controlled study, one retrospective study and one meta-analysis of small randomized studies) and there is need for a large multicentre randomized controlled study to confirm these findings, as suggested by the international consensus conference on this topic published in 2011 (Landoni et al 2011).

The purpose is to provide a large multicentre controlled randomized trial to demonstrate that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass).

The results of this study can support the use of volatile agents in all CABG procedures worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be reduced from 3% to 2% using volatile agents).

Condition or disease Intervention/treatment Phase
Aortocoronary Bypass Cardiac Surgery Coronary Artery Bypass Grafting Drug: desflurane, isoflurane, sevoflurane Drug: total intravenous anesthetics Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Volatile Anesthetics to Reduce Mortality in Cardiac Surgery: A Multicentre Randomized Controlled Study
Study Start Date : April 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: volatile anesthetics (desflurane, isoflurane, sevoflurane) Drug: desflurane, isoflurane, sevoflurane
Active Comparator: total intravenous anesthesia Drug: total intravenous anesthetics

Outcome Measures

Primary Outcome Measures :
  1. mortality [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age >18 years
  • written informed consent
  • scheduled procedures
  • planned isolated CABG (multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed

Exclusion Criteria:

  • pregnancy
  • planned valve surgery or surgery on the aorta
  • planned locoregional anesthesia without general anesthesia
  • unstable or ongoing angina
  • recent (< 1 month) or ongoing acute myocardial infarction
  • use of sulfonylurea, theophylline or allopurinol
  • previous unusual response to an anesthetic agent
  • inclusion in other randomised controlled studies in the previous 30 days
  • any general anesthesia performed in the previous 30 days
  • emergency operation (not scheduled)
  • Kidney or liver transplant in medical history
  • Liver cirrhosis (Child B or C)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105610

Contact: giovanni landoni, Prof landoni.giovanni@hsr.it

Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center - Bahrain Recruiting
Bahrain, Bahrain
Contact: Nazar Bukamal, MD         
Hospital das Clínicas da Faculdade de Medicina da USP - Istituto do Coracao Recruiting
Sao Paulo, Barazil, Brazil
Contact: Ludhmila Hajjar, MD         
Dante Pazzanese Institute of Cardiology Recruiting
Sao Paulo, Brazil
Contact: Caetano Nigro, MD         
Heart Center Pontica Not yet recruiting
Burgas, Bulgaria
Contact: Nikolay Uvaliev, MD         
University Hospital Dubrava Recruiting
Dubrava, Croatia
Contact: Nikola Bradic, MD         
General University Hospital, Charles University Recruiting
Prague, Czech Republic, Czechia
Contact: Jan Kunstýř, MD         
Institute for Clinical and Experimental Medicine Recruiting
Prague, Czech Republic, Czechia
Contact: Riha Hynek, MD         
Mansoura University hospitals Not yet recruiting
Egypt, Egypt
Contact: Mohamed R El-Tahan, MD         
Sub-Investigator: Tarek Habeeb, MD         
Faculty of Medicine - Zagazig University Recruiting
Zagazig, Egypt
Contact: Abeer Elnakera, MD         
Policlinico Universitario Magna Graecia Not yet recruiting
Catanzaro, Italy
Contact: Gabriele Alvaro, MD         
Ospedale San Raffaele di Milano, Italy Recruiting
Milano, Italy, 20132
Contact: giovanni landoni, prof       landoni.giovanni@hsr.it   
Azienda Ospedaliera di Padova Not yet recruiting
Padova, Italy
Contact: Cristiana Carollo, MD         
Sub-Investigator: Demetrio Pittarello, MD         
Azienda Ospedaliera San Camillo-Forlanini Recruiting
Roma, Italy
Contact: Luca Severi, MD         
University Malaya Medical Centre Not yet recruiting
Lumpur, Malaysia
Contact: Wang CY, MD         
Hospital Santa Maria Recruiting
Lisbon, Portugal
Contact: Fernanda Santos Silva, MD         
Russian Federation
Ural Institute of Cardiology Recruiting
Ekaterinburg, Russia, Russian Federation
Contact: Andrey Lozovskiy, MD         
Federal Centre for Cardiac Surgery Recruiting
Astrakhan, Russian Federation
Contact: Vadim Pasyuga Pasyuga, MD         
Scientific Research Institute for Complex Issues of Cardiovascular Disease Recruiting
Kemerovo, Russian Federation
Contact: Evgeny Grigoryev, MD         
Moscow Clinical Regional Research Institute Recruiting
Moscow, Russian Federation
Contact: Valery Likhvantsev, MD         
Negovskiy Reanimatology Research Institute Recruiting
Moscow, Russian Federation
Contact: Valery Likhvantsev, MD         
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation
Contact: Vladimir Lomivorotov, MD         
Federal Almazov Medical Research Centre Recruiting
Saint Petersburg, Russian Federation
Contact: Evgeny Homenko, MD         
Contact: Andrei Bautin, MD         
Institute of Cardiovascular Diseases "Dedinje" Recruiting
Belgrade, Serbia
Contact: Miomir Jovic, MD         
Sub-Investigator: Gordana Gazivoda, MD         
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Study Chair: alberto zangrillo, Prof Vita-Salute University of Milano
More Information

Responsible Party: Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT02105610     History of Changes
Other Study ID Numbers: VOLATILE/38/OSR
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Keywords provided by Giovanni Landoni, Università Vita-Salute San Raffaele:
volatile anesthetics
cardiac surgery
intensive care

Additional relevant MeSH terms:
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General