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Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial
BACKGROUND: Postoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac ou...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5944092/ https://www.ncbi.nlm.nih.gov/pubmed/29743101 http://dx.doi.org/10.1186/s13063-018-2620-9 |
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author | Funcke, Sandra Saugel, Bernd Koch, Christian Schulte, Dagmar Zajonz, Thomas Sander, Michael Gratarola, Angelo Ball, Lorenzo Pelosi, Paolo Spadaro, Savino Ragazzi, Riccardo Volta, Carlo Alberto Mencke, Thomas Zitzmann, Amelie Neukirch, Benedikt Azparren, Gonzalo Giné, Marta Moral, Vicky Pinnschmidt, Hans Otto Díaz-Cambronero, Oscar Estelles, Maria Jose Alberola Velez, Marisol Echeverri Montañes, Maria Vila Belda, Javier Soro, Marina Puig, Jaume Reuter, Daniel Arnulf Haas, Sebastian Alois |
author_facet | Funcke, Sandra Saugel, Bernd Koch, Christian Schulte, Dagmar Zajonz, Thomas Sander, Michael Gratarola, Angelo Ball, Lorenzo Pelosi, Paolo Spadaro, Savino Ragazzi, Riccardo Volta, Carlo Alberto Mencke, Thomas Zitzmann, Amelie Neukirch, Benedikt Azparren, Gonzalo Giné, Marta Moral, Vicky Pinnschmidt, Hans Otto Díaz-Cambronero, Oscar Estelles, Maria Jose Alberola Velez, Marisol Echeverri Montañes, Maria Vila Belda, Javier Soro, Marina Puig, Jaume Reuter, Daniel Arnulf Haas, Sebastian Alois |
author_sort | Funcke, Sandra |
collection | PubMed |
description | BACKGROUND: Postoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac output optimization is able to reduce mortality and postoperative moderate and severe complications as a major determinant of the patients’ postoperative quality of life, as well as health care costs. METHODS/DESIGN: This is a multi-center, international, prospective, randomized trial in 380 patients undergoing major abdominal surgery including visceral, urological, and gynecological operations. Eligible patients will be randomly allocated to two treatment arms within the participating centers. Patients of the intervention group will be treated perioperatively following a specific hemodynamic therapy algorithm based on pulse-pressure variation (PPV) and individualized optimization of cardiac output assessed by pulse-contour analysis (ProAQT© device; Pulsion Medical Systems, Feldkirchen, Germany). Patients in the control group will be treated according to standard local care based on established basic hemodynamic treatment. The primary endpoint is a composite comprising the occurrence of moderate or severe postoperative complications or death within 28 days post surgery. Secondary endpoints are: (1) the number of moderate and severe postoperative complications in total, per patient and for each individual complication; (2) the occurrence of at least one of these complications on days 1, 3, 5, 7, and 28 in total and for every complication; (3) the days alive and free of mechanical ventilation, vasopressor therapy and renal replacement therapy, length of intensive care unit, and hospital stay at day 7 and day 28; and (4) mortality and quality of life, assessed by the EQ-5D-5L™ questionnaire, after 6 months. DISCUSSION: This is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality. TRIAL REGISTRATION: Trial registration: NCT03021525. Registered on 12 January 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2620-9) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5944092 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-59440922018-05-14 Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial Funcke, Sandra Saugel, Bernd Koch, Christian Schulte, Dagmar Zajonz, Thomas Sander, Michael Gratarola, Angelo Ball, Lorenzo Pelosi, Paolo Spadaro, Savino Ragazzi, Riccardo Volta, Carlo Alberto Mencke, Thomas Zitzmann, Amelie Neukirch, Benedikt Azparren, Gonzalo Giné, Marta Moral, Vicky Pinnschmidt, Hans Otto Díaz-Cambronero, Oscar Estelles, Maria Jose Alberola Velez, Marisol Echeverri Montañes, Maria Vila Belda, Javier Soro, Marina Puig, Jaume Reuter, Daniel Arnulf Haas, Sebastian Alois Trials Study Protocol BACKGROUND: Postoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac output optimization is able to reduce mortality and postoperative moderate and severe complications as a major determinant of the patients’ postoperative quality of life, as well as health care costs. METHODS/DESIGN: This is a multi-center, international, prospective, randomized trial in 380 patients undergoing major abdominal surgery including visceral, urological, and gynecological operations. Eligible patients will be randomly allocated to two treatment arms within the participating centers. Patients of the intervention group will be treated perioperatively following a specific hemodynamic therapy algorithm based on pulse-pressure variation (PPV) and individualized optimization of cardiac output assessed by pulse-contour analysis (ProAQT© device; Pulsion Medical Systems, Feldkirchen, Germany). Patients in the control group will be treated according to standard local care based on established basic hemodynamic treatment. The primary endpoint is a composite comprising the occurrence of moderate or severe postoperative complications or death within 28 days post surgery. Secondary endpoints are: (1) the number of moderate and severe postoperative complications in total, per patient and for each individual complication; (2) the occurrence of at least one of these complications on days 1, 3, 5, 7, and 28 in total and for every complication; (3) the days alive and free of mechanical ventilation, vasopressor therapy and renal replacement therapy, length of intensive care unit, and hospital stay at day 7 and day 28; and (4) mortality and quality of life, assessed by the EQ-5D-5L™ questionnaire, after 6 months. DISCUSSION: This is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality. TRIAL REGISTRATION: Trial registration: NCT03021525. Registered on 12 January 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2620-9) contains supplementary material, which is available to authorized users. BioMed Central 2018-05-09 /pmc/articles/PMC5944092/ /pubmed/29743101 http://dx.doi.org/10.1186/s13063-018-2620-9 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Funcke, Sandra Saugel, Bernd Koch, Christian Schulte, Dagmar Zajonz, Thomas Sander, Michael Gratarola, Angelo Ball, Lorenzo Pelosi, Paolo Spadaro, Savino Ragazzi, Riccardo Volta, Carlo Alberto Mencke, Thomas Zitzmann, Amelie Neukirch, Benedikt Azparren, Gonzalo Giné, Marta Moral, Vicky Pinnschmidt, Hans Otto Díaz-Cambronero, Oscar Estelles, Maria Jose Alberola Velez, Marisol Echeverri Montañes, Maria Vila Belda, Javier Soro, Marina Puig, Jaume Reuter, Daniel Arnulf Haas, Sebastian Alois Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial |
title | Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial |
title_full | Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial |
title_fullStr | Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial |
title_full_unstemmed | Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial |
title_short | Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial |
title_sort | individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (ipegasus trial): study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5944092/ https://www.ncbi.nlm.nih.gov/pubmed/29743101 http://dx.doi.org/10.1186/s13063-018-2620-9 |
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