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MortalitY in caRdIAc surgery (MYRIAD): A randomizeD controlled trial of volatile anesthetics. Rationale and design.

Authors :
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
Source :
Contemporary clinical trials [Contemp Clin Trials] 2017 Aug; Vol. 59, pp. 38-43. Date of Electronic Publication: 2017 May 19.
Publication Year :
2017

Abstract

Objective: There is initial evidence that the use of volatile anesthetics can reduce the postoperative release of cardiac troponin I, the need for inotropic support, and the number of patients requiring prolonged hospitalization following coronary artery bypass graft (CABG) surgery. Nevertheless, small randomized controlled trials have failed to demonstrate a survival advantage. Thus, whether volatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain. An adequately powered randomized controlled trial appears desirable.<br />Design: Single blinded, international, multicenter randomized controlled trial with 1:1 allocation ratio.<br />Setting: Tertiary and University hospitals.<br />Interventions: Patients (n=10,600) undergoing coronary artery bypass graft will be randomized to receive either volatile anesthetic as part of the anesthetic plan, or total intravenous anesthesia.<br />Measurements and Main Results: The primary end point of the study will be one-year mortality (any cause). Secondary endpoints will be 30-day mortality; 30-day death or non-fatal myocardial infarction (composite endpoint); cardiac mortality at 30day and at one year; incidence of hospital re-admission during the one year follow-up period and duration of intensive care unit, and hospital stay. The sample size is based on the hypothesis that volatile anesthetics will reduce 1-year unadjusted mortality from 3% to 2%, using a two-sided alpha error of 0.05, and a power of 0.9.<br />Conclusions: The trial will determine whether the simple intervention of adding a volatile anesthetic, an intervention that can be implemented by all anesthesiologists, can improve one-year survival in patients undergoing coronary artery bypass graft surgery.<br /> (Copyright © 2017 Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1559-2030
Volume :
59
Database :
MEDLINE
Journal :
Contemporary clinical trials
Publication Type :
Academic Journal
Accession number :
28533194
Full Text :
https://doi.org/10.1016/j.cct.2017.05.011