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Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial
BACKGROUND: The detrimental effects of inotropes are well-known, and in many fields they are only used within a goal-directed therapy approach. Nevertheless, standard management in many centers includes administering inotropes to all patients undergoing cardiac surgery to prevent low cardiac output...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7838231/ https://www.ncbi.nlm.nih.gov/pubmed/33496877 http://dx.doi.org/10.1186/s13613-021-00808-6 |
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author | Franco, Rafael Alves de Almeida, Juliano Pinheiro Landoni, Giovanni Scheeren, Thomas W. L. Galas, Filomena Regina Barbosa Gomes Fukushima, Julia Tizue Zefferino, Suely Nardelli, Pasquale de Albuquerque Piccioni, Marilde Arita, Elisandra Cristina Trevisan Calvo Park, Clarice Hyesuk Lee Cunha, Ligia Cristina Camara de Oliveira, Gisele Queiroz Costa, Isabela Bispo Santos da Silva Kalil Filho, Roberto Jatene, Fabio Biscegli Hajjar, Ludhmila Abrahão |
author_facet | Franco, Rafael Alves de Almeida, Juliano Pinheiro Landoni, Giovanni Scheeren, Thomas W. L. Galas, Filomena Regina Barbosa Gomes Fukushima, Julia Tizue Zefferino, Suely Nardelli, Pasquale de Albuquerque Piccioni, Marilde Arita, Elisandra Cristina Trevisan Calvo Park, Clarice Hyesuk Lee Cunha, Ligia Cristina Camara de Oliveira, Gisele Queiroz Costa, Isabela Bispo Santos da Silva Kalil Filho, Roberto Jatene, Fabio Biscegli Hajjar, Ludhmila Abrahão |
author_sort | Franco, Rafael Alves |
collection | PubMed |
description | BACKGROUND: The detrimental effects of inotropes are well-known, and in many fields they are only used within a goal-directed therapy approach. Nevertheless, standard management in many centers includes administering inotropes to all patients undergoing cardiac surgery to prevent low cardiac output syndrome and its implications. Randomized evidence in favor of a patient-tailored, inotrope-sparing approach is still lacking. We designed a randomized controlled noninferiority trial in patients undergoing cardiac surgery with normal ejection fraction to assess whether an dobutamine-sparing strategy (in which the use of dobutamine was guided by hemodynamic evidence of low cardiac output associated with signs of inadequate tissue perfusion) was noninferior to an inotrope-to-all strategy (in which all patients received dobutamine). RESULTS: A total of 160 patients were randomized to the dobutamine-sparing strategy (80 patients) or to the dobutamine-to-all approach (80 patients). The primary composite endpoint of 30-day mortality or occurrence of major cardiovascular complications (arrhythmias, acute myocardial infarction, low cardiac output syndrome and stroke or transient ischemic attack) occurred in 25/80 (31%) patients of the dobutamine-sparing group (p = 0.74) and 27/80 (34%) of the dobutamine-to-all group. There were no significant differences between groups regarding the incidence of acute kidney injury, prolonged mechanical ventilation, intensive care unit or hospital length of stay. DISCUSSION: Although it is common practice in many centers to administer inotropes to all patients undergoing cardiac surgery, a dobutamine-sparing strategy did not result in an increase of mortality or occurrence of major cardiovascular events when compared to a dobutamine-to-all strategy. Further research is needed to assess if reducing the administration of inotropes can improve outcomes in cardiac surgery. Trial registration ClinicalTrials.gov, NCT02361801. Registered Feb 2nd, 2015. https://clinicaltrials.gov/ct2/show/NCT02361801 |
format | Online Article Text |
id | pubmed-7838231 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-78382312021-02-04 Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial Franco, Rafael Alves de Almeida, Juliano Pinheiro Landoni, Giovanni Scheeren, Thomas W. L. Galas, Filomena Regina Barbosa Gomes Fukushima, Julia Tizue Zefferino, Suely Nardelli, Pasquale de Albuquerque Piccioni, Marilde Arita, Elisandra Cristina Trevisan Calvo Park, Clarice Hyesuk Lee Cunha, Ligia Cristina Camara de Oliveira, Gisele Queiroz Costa, Isabela Bispo Santos da Silva Kalil Filho, Roberto Jatene, Fabio Biscegli Hajjar, Ludhmila Abrahão Ann Intensive Care Research BACKGROUND: The detrimental effects of inotropes are well-known, and in many fields they are only used within a goal-directed therapy approach. Nevertheless, standard management in many centers includes administering inotropes to all patients undergoing cardiac surgery to prevent low cardiac output syndrome and its implications. Randomized evidence in favor of a patient-tailored, inotrope-sparing approach is still lacking. We designed a randomized controlled noninferiority trial in patients undergoing cardiac surgery with normal ejection fraction to assess whether an dobutamine-sparing strategy (in which the use of dobutamine was guided by hemodynamic evidence of low cardiac output associated with signs of inadequate tissue perfusion) was noninferior to an inotrope-to-all strategy (in which all patients received dobutamine). RESULTS: A total of 160 patients were randomized to the dobutamine-sparing strategy (80 patients) or to the dobutamine-to-all approach (80 patients). The primary composite endpoint of 30-day mortality or occurrence of major cardiovascular complications (arrhythmias, acute myocardial infarction, low cardiac output syndrome and stroke or transient ischemic attack) occurred in 25/80 (31%) patients of the dobutamine-sparing group (p = 0.74) and 27/80 (34%) of the dobutamine-to-all group. There were no significant differences between groups regarding the incidence of acute kidney injury, prolonged mechanical ventilation, intensive care unit or hospital length of stay. DISCUSSION: Although it is common practice in many centers to administer inotropes to all patients undergoing cardiac surgery, a dobutamine-sparing strategy did not result in an increase of mortality or occurrence of major cardiovascular events when compared to a dobutamine-to-all strategy. Further research is needed to assess if reducing the administration of inotropes can improve outcomes in cardiac surgery. Trial registration ClinicalTrials.gov, NCT02361801. Registered Feb 2nd, 2015. https://clinicaltrials.gov/ct2/show/NCT02361801 Springer International Publishing 2021-01-26 /pmc/articles/PMC7838231/ /pubmed/33496877 http://dx.doi.org/10.1186/s13613-021-00808-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Research Franco, Rafael Alves de Almeida, Juliano Pinheiro Landoni, Giovanni Scheeren, Thomas W. L. Galas, Filomena Regina Barbosa Gomes Fukushima, Julia Tizue Zefferino, Suely Nardelli, Pasquale de Albuquerque Piccioni, Marilde Arita, Elisandra Cristina Trevisan Calvo Park, Clarice Hyesuk Lee Cunha, Ligia Cristina Camara de Oliveira, Gisele Queiroz Costa, Isabela Bispo Santos da Silva Kalil Filho, Roberto Jatene, Fabio Biscegli Hajjar, Ludhmila Abrahão Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial |
title | Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial |
title_full | Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial |
title_fullStr | Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial |
title_full_unstemmed | Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial |
title_short | Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial |
title_sort | dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7838231/ https://www.ncbi.nlm.nih.gov/pubmed/33496877 http://dx.doi.org/10.1186/s13613-021-00808-6 |
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