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Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial
INTRODUCTION: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Sociedade Brasileira de Cirurgia Cardiovascular
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5701109/ https://www.ncbi.nlm.nih.gov/pubmed/29211225 http://dx.doi.org/10.21470/1678-9741-2017-0196 |
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author | Mejía, Omar Asdrúbal Vilca Sá, Michel Pompeu Barros Oliveira Deininger, Maurilio Onofre Dallan, Luís Roberto Palma Segalote, Rodrigo Coelho de Oliveira, Marco Antonio Praça Atik, Fernando Antibas dos Santos, Magaly Arrais Silva, Pedro Gabriel Melo de Barros e Milani, Rodrigo Mussi Hueb, Alexandre Ciappina Monteiro, Rosangela Lima, Ricardo Carvalho Lisboa, Luiz Augusto Ferreira Dallan, Luís Alberto Oliveira Puskas, John Jatene, Fabio Biscegli |
author_facet | Mejía, Omar Asdrúbal Vilca Sá, Michel Pompeu Barros Oliveira Deininger, Maurilio Onofre Dallan, Luís Roberto Palma Segalote, Rodrigo Coelho de Oliveira, Marco Antonio Praça Atik, Fernando Antibas dos Santos, Magaly Arrais Silva, Pedro Gabriel Melo de Barros e Milani, Rodrigo Mussi Hueb, Alexandre Ciappina Monteiro, Rosangela Lima, Ricardo Carvalho Lisboa, Luiz Augusto Ferreira Dallan, Luís Alberto Oliveira Puskas, John Jatene, Fabio Biscegli |
author_sort | Mejía, Omar Asdrúbal Vilca |
collection | PubMed |
description | INTRODUCTION: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. METHODS: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. DISCUSSION: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29(th) 2014; last updated on March 21(st) 2016. |
format | Online Article Text |
id | pubmed-5701109 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Sociedade Brasileira de Cirurgia Cardiovascular |
record_format | MEDLINE/PubMed |
spelling | pubmed-57011092017-11-28 Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial Mejía, Omar Asdrúbal Vilca Sá, Michel Pompeu Barros Oliveira Deininger, Maurilio Onofre Dallan, Luís Roberto Palma Segalote, Rodrigo Coelho de Oliveira, Marco Antonio Praça Atik, Fernando Antibas dos Santos, Magaly Arrais Silva, Pedro Gabriel Melo de Barros e Milani, Rodrigo Mussi Hueb, Alexandre Ciappina Monteiro, Rosangela Lima, Ricardo Carvalho Lisboa, Luiz Augusto Ferreira Dallan, Luís Alberto Oliveira Puskas, John Jatene, Fabio Biscegli Braz J Cardiovasc Surg Trial Protocol INTRODUCTION: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. METHODS: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. DISCUSSION: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29(th) 2014; last updated on March 21(st) 2016. Sociedade Brasileira de Cirurgia Cardiovascular 2017 /pmc/articles/PMC5701109/ /pubmed/29211225 http://dx.doi.org/10.21470/1678-9741-2017-0196 Text en http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Trial Protocol Mejía, Omar Asdrúbal Vilca Sá, Michel Pompeu Barros Oliveira Deininger, Maurilio Onofre Dallan, Luís Roberto Palma Segalote, Rodrigo Coelho de Oliveira, Marco Antonio Praça Atik, Fernando Antibas dos Santos, Magaly Arrais Silva, Pedro Gabriel Melo de Barros e Milani, Rodrigo Mussi Hueb, Alexandre Ciappina Monteiro, Rosangela Lima, Ricardo Carvalho Lisboa, Luiz Augusto Ferreira Dallan, Luís Alberto Oliveira Puskas, John Jatene, Fabio Biscegli Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial |
title | Off-pump versus On-pump Coronary Artery Bypass
Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter
Randomized Controlled Trial |
title_full | Off-pump versus On-pump Coronary Artery Bypass
Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter
Randomized Controlled Trial |
title_fullStr | Off-pump versus On-pump Coronary Artery Bypass
Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter
Randomized Controlled Trial |
title_full_unstemmed | Off-pump versus On-pump Coronary Artery Bypass
Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter
Randomized Controlled Trial |
title_short | Off-pump versus On-pump Coronary Artery Bypass
Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter
Randomized Controlled Trial |
title_sort | off-pump versus on-pump coronary artery bypass
grafting in frail patients: study protocol for the fragile multicenter
randomized controlled trial |
topic | Trial Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5701109/ https://www.ncbi.nlm.nih.gov/pubmed/29211225 http://dx.doi.org/10.21470/1678-9741-2017-0196 |
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