MYRIAD: Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

Sponsor

Università Vita-Salute San Raffaele (Other)

Overall Status

Completed

CT.gov ID

NCT02105610

Collaborator

(none)

5,400

Enrollment

Locations

Arms

52.6

Actual Duration (Months)

150

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

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

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

Actual Study Start Date :

Apr 14, 2014

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Sep 1, 2018

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

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

mortality [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center - Bahrain	Bahrein		Bahrain
2	Hospital das Clínicas da Faculdade de Medicina da USP - Istituto do Coracao	Sao Paulo	Barazil	Brazil
3	Dante Pazzanese Institute of Cardiology	Sao Paulo		Brazil
4	Heart Center Pontica	Burgas		Bulgaria
5	Beijing Anzhen Hospital, Capital Medical University	Beijing		China
6	The Second Xiangya Hospital of Central South University	Changsha		China
7	Wuhan Asia Heart Hospital	Hubei		China
8	1st Affiliated Hospital of Fourth Military University	Xi'an		China
9	University Hospital Dubrava	Dubrava		Croatia
10	General University Hospital, Charles University	Prague	Czech Republic	Czechia
11	Institute for Clinical and Experimental Medicine	Prague	Czech Republic	Czechia
12	Mansoura University hospitals	Egypt		Egypt
13	Faculty of Medicine - Zagazig University	Zagazig		Egypt
14	Policlinico San Orsola-Malpighi	Bologna		Italy
15	Spedali Civili	Brescia		Italy
16	Policlinico Universitario Magna Graecia	Catanzaro		Italy
17	Ospedale San Raffaele di Milano, Italy	Milano		Italy	20132
18	Humanitas	Milano		Italy
19	Azienda Ospedaliera di Padova	Padova		Italy
20	Azienda Ospedaliera San Camillo-Forlanini	Roma		Italy
21	Policlinico Universitario Campus Biomedico	Roma		Italy
22	AOU Città della Salute e della Scienza	Torino		Italy
23	Hospital Serdang	Lumpur		Malaysia
24	University Malaya Medical Centre	Lumpur		Malaysia
25	Hospital Pulau Pinang	Penang		Malaysia
26	Sarawak General Hospital	Sarawak		Malaysia
27	Hospital Santa Maria	Lisbon		Portugal
28	Federal Centre for Cardiac Surgery	Astrakhan		Russian Federation
29	Ural Institute of Cardiology	Ekaterinburg		Russian Federation
30	Scientific Research Institute for Complex Issues of Cardiovascular Disease	Kemerovo		Russian Federation
31	Moscow Clinical Regional Research Institute	Moscow		Russian Federation
32	Negovskiy Reanimatology Research Institute	Moscow		Russian Federation
33	State Research Institute of Circulation Pathology	Novosibirsk		Russian Federation
34	Federal Almazov Medical Research Centre	Saint Petersburg		Russian Federation
35	King Abdullah Medical City - KAMC	Mecca		Saudi Arabia
36	Institute of Cardiovascular Diseases "Dedinje"	Belgrade		Serbia