Cargando…

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 (...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Sociedade Brasileira de Cirurgia Cardiovascular 2017
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
_version_ 1783281268347109376
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
work_keys_str_mv AT mejiaomarasdrubalvilca offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT samichelpompeubarrosoliveira offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT deiningermaurilioonofre offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT dallanluisrobertopalma offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT segaloterodrigocoelho offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT deoliveiramarcoantoniopraca offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT atikfernandoantibas offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT dossantosmagalyarrais offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT silvapedrogabrielmelodebarrose offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT milanirodrigomussi offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT huebalexandreciappina offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT monteirorosangela offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT limaricardocarvalho offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT lisboaluizaugustoferreira offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT dallanluisalbertooliveira offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT puskasjohn offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial
AT jatenefabiobiscegli offpumpversusonpumpcoronaryarterybypassgraftinginfrailpatientsstudyprotocolforthefragilemulticenterrandomizedcontrolledtrial