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Volatile Anesthetics to Reduce Mortality in Cardiac Surgery (MYRIAD)

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ClinicalTrials.gov Identifier: NCT02105610
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5400 participants
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
Actual Primary Completion Date : October 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


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
Criteria

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)

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


Locations
Bahrain
Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center - Bahrain
Bahrain, Bahrain
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP - Istituto do Coracao
Sao Paulo, Barazil, Brazil
Dante Pazzanese Institute of Cardiology
Sao Paulo, Brazil
Bulgaria
Heart Center Pontica
Burgas, Bulgaria
Croatia
University Hospital Dubrava
Dubrava, Croatia
Czechia
General University Hospital, Charles University
Prague, Czech Republic, Czechia
Institute for Clinical and Experimental Medicine
Prague, Czech Republic, Czechia
Egypt
Mansoura University hospitals
Egypt, Egypt
Faculty of Medicine - Zagazig University
Zagazig, Egypt
Italy
Policlinico Universitario Magna Graecia
Catanzaro, Italy
Ospedale San Raffaele di Milano, Italy
Milano, Italy, 20132
Azienda Ospedaliera di Padova
Padova, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, Italy
Malaysia
University Malaya Medical Centre
Lumpur, Malaysia
Portugal
Hospital Santa Maria
Lisbon, Portugal
Russian Federation
Federal Centre for Cardiac Surgery
Astrakhan, Russian Federation
Ural Institute of Cardiology
Ekaterinburg, Russian Federation
Scientific Research Institute for Complex Issues of Cardiovascular Disease
Kemerovo, Russian Federation
Moscow Clinical Regional Research Institute
Moscow, Russian Federation
Negovskiy Reanimatology Research Institute
Moscow, Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation
Federal Almazov Medical Research Centre
Saint Petersburg, Russian Federation
Serbia
Institute of Cardiovascular Diseases "Dedinje"
Belgrade, Serbia
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Chair: alberto zangrillo, Prof Vita-Salute University of Milano

Additional Information:
Publications:
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: March 22, 2018
Last Verified: March 2018

Keywords provided by Giovanni Landoni, Università Vita-Salute San Raffaele:
volatile anesthetics
desflurane
isoflurane
sevoflurane
TIVA
cardiac surgery
mortality
anesthesia
intensive care

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