Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

Cardiac Surgery Clinical Trial

— MYRIAD  

Official title:

Volatile Anesthetics to Reduce Mortality in Cardiac Surgery: A Multicentre Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105610
• Other study ID #: VOLATILE/38/OSR
• Status: Completed
• Phase: Phase 4
• Start date: April 14, 2014
• Est. completion date: September 2018

Study information

• Verified date: March 2019
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5400
• Est. completion date: September 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortocoronary Bypass
• Cardiac Surgery
• Coronary Artery Bypass Grafting

Intervention

Drug:
• desflurane, isoflurane, sevoflurane

• total intravenous anesthetics

Locations

Country	Name	City	State
Bahrain	Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center - Bahrain	Bahrein
Brazil	Dante Pazzanese Institute of Cardiology	Sao Paulo
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP - Istituto do Coracao	Sao Paulo	Barazil
Bulgaria	Heart Center Pontica	Burgas
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha
China	Wuhan Asia Heart Hospital	Hubei
China	1st Affiliated Hospital of Fourth Military University	Xi'an
Croatia	University Hospital Dubrava	Dubrava
Czechia	General University Hospital, Charles University	Prague	Czech Republic
Czechia	Institute for Clinical and Experimental Medicine	Prague	Czech Republic
Egypt	Mansoura University hospitals	Egypt
Egypt	Faculty of Medicine - Zagazig University	Zagazig
Italy	Policlinico San Orsola-Malpighi	Bologna
Italy	Spedali Civili	Brescia
Italy	Policlinico Universitario Magna Graecia	Catanzaro
Italy	Humanitas	Milano
Italy	Ospedale San Raffaele di Milano, Italy	Milano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliera San Camillo-Forlanini	Roma
Italy	Policlinico Universitario Campus Biomedico	Roma
Italy	AOU Città della Salute e della Scienza	Torino
Malaysia	Hospital Serdang	Lumpur
Malaysia	University Malaya Medical Centre	Lumpur
Malaysia	Hospital Pulau Pinang	Penang
Malaysia	Sarawak General Hospital	Sarawak
Portugal	Hospital Santa Maria	Lisbon
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
Saudi Arabia	King Abdullah Medical City - KAMC	Mecca
Serbia	Institute of Cardiovascular Diseases "Dedinje"	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Countries where clinical trial is conducted

Bahrain,  Brazil,  Bulgaria,  China,  Croatia,  Czechia,  Egypt,  Italy,  Malaysia,  Portugal,  Russian Federation,  Saudi Arabia,  Serbia, 

References & Publications (3)

Landoni G, Greco T, Biondi-Zoccai G, Nigro Neto C, Febres D, Pintaudi M, Pasin L, Cabrini L, Finco G, Zangrillo A. Anaesthetic drugs and survival: a Bayesian network meta-analysis of randomized trials in cardiac surgery. Br J Anaesth. 2013 Dec;111(6):886-96. doi: 10.1093/bja/aet231. Epub 2013 Jul 12. — View Citation

Landoni G, Lomivorotov V, Pisano A, Nigro Neto C, Benedetto U, Biondi Zoccai G, Gemma M, Frassoni S, Agrò FE, Baiocchi M, Barbosa Gomes Galas FR, Bautin A, Bradic N, Carollo C, Crescenzi G, Elnakera AM, El-Tahan MR, Fominskiy E, Farag AG, Gazivoda G, Gianni S, Grigoryev E, Guarracino F, Hanafi S, Huang W, Kunst G, Kunstyr J, Lei C, Lembo R, Li ZJ, Likhvantsev V, Lozovskiy A, Ma J, Monaco F, Navalesi P, Nazar B, Pasyuga V, Porteri E, Royse C, Ruggeri L, Riha H, Santos Silva F, Severi L, Shmyrev V, Uvaliev N, Wang CB, Wang CY, Winterton D, Yong CY, Yu J, Bellomo R, Zangrillo A. MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design. Contemp Clin Trials. 2017 Aug;59:38-43. doi: 10.1016/j.cct.2017.05.011. Epub 2017 May 19. — View Citation

Landoni G, Rodseth RN, Santini F, Ponschab M, Ruggeri L, Székely A, Pasero D, Augoustides JG, Del Sarto PA, Krzych LJ, Corcione A, Slullitel A, Cabrini L, Le Manach Y, Almeida RM, Bignami E, Biondi-Zoccai G, Bove T, Caramelli F, Cariello C, Carpanese A, Clarizia L, Comis M, Conte M, Covello RD, De Santis V, Feltracco P, Giordano G, Pittarello D, Gottin L, Guarracino F, Morelli A, Musu M, Pala G, Pasin L, Pezzoli I, Paternoster G, Remedi R, Roasio A, Zucchetti M, Petrini F, Finco G, Ranieri M, Zangrillo A. Randomized evidence for reduction of perioperative mortality. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):764-72. doi: 10.1053/j.jvca.2012.04.018. Epub 2012 Jun 20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		1 year

External Links

•   CV Prof Landoni