Journal article
Authors list: Edwards, Mark R.; Forbes, Gordon; MacDonald, Neil; Berdunov, Vladislav; Mihaylova, Borislava; Dias, Priyanthi; Thomson, Ann; Grocott, Michael P. W.; Mythen, Monty G.; Gillies, Mike A.; Sander, Michael; Phan, Tuong D.; Evered, Lisbeth; Wijeysundera, Duminda N.; McCluskey, Stuart A.; Aldecoa, Cesar; Ripolles-Melchor, Javier; Hofer, Christoph K.; Abukhudair, Hussein; Szczeklik, Wojciech; Grigoras, Ioana; Hajjar, Ludhmila A.; Kahan, Brennan C.; Pearse, Rupert M.; MacDonald, Neil; Abbott, Tom; Martin, Tim; Januszewska, Marta; Niebrzegowska, Edyta; Bekele, Solana; Pates, Katherine; Haines, Ryan; Walker, Sophie; Fowler, Alexander; Oliveira, Monica; Whalley, Jan; Stephens, Tim; Amaral, Vanessa Da Silva; May, Shaun; Manou, Vasi; Jones, Tim; Dunkley, Steven; Pakats, Mari-Liis; Griffiths, Bethan; Fernandez, Maria; Edwards, Mark; Jonas, Max; Bolger, Clare; Collings, Nikki; Burnish, Rachel; Kelleher, Mort; Dawson, Heidi; Lang, Alastair; Campbell, Rachael; Rea, Nicola; Clark, Sarah; Blunt, Mark; Rosbergen, Melissa; Hodgson, Ruth; Wittenberg, Marc; Filipe, Helder; Gleeson, Yvonne; Pakou, Glykeria; Szakmany, Tamas; Gunter, Una; Hodkinson, Gemma; Reay, Michael; Gidda, Ranjit; Allcock, Clare; Cole, Andrea; Watts, Angela; Gardner, Wendy; Tindall, Mark; Anumakonda, Vikram; Agarwal, Nipun; Price, Tracey; Clark, Philip; Thompson, Robert; Fowler, Susan; Gray, Karan; McGregor, Amanda; Smith, Tim; Wilson, Toni; Guha, Abhik; Hodgson, Adrian; McSkeane, Anna; Barberis, Luigi; Mohamed, Mohamed; Prentice, Scott; Saunders, Zoe; Ratnam, Valli; Pawa, Nikhil; Sayan, Amrinder; Thankachen, Mini; Svensson, Marie-Louise; Raj, Ashok; Ahmad, Nadeem; Ivermee, Clare; Cashman, Josephine; Smee, Elizabeth; Kanapeckaite, Lina; Tuong Phan; Evered, Lis; Corcoran, Petrea; Fitzgerald, Emily; Peyton, Philip; Buckley, Aisling; Baulch, Sarah; Claxton, Gayle; Harris, Saskia; Sidiropolous, Sofia; de Almeida, Juliano Pinheiro; Simoes, Claudia; Galas, Filomena Regina B. G.; Hajjar, Ludhmila Abrahao; Camara, Ligia; Malbouisson, Luiz Marcelo Sa; Soares, Sanzio Dupim; Fernandes, Claudia Regina; Joaquim, Eduardo Henrique Giroud; Stefani, Luciana Cadore; Falcao, Luiz Fernando; Salgado, Marcello; Guimaraes, Gabriel Nunes; Gomes, Mauricio Daher Andrade; Lineburger, Eric; Navarro, Lais; Salles, Luiz Carlos; Azi, Liana Maria Torres de Araujo; Prado, Ricardo Goncalves; Benedetti, Roberto Henrique; de Godoy, Eudes Paiva; Bastos, Flavio Andrade; da Silva, Ricardo Jose Curioso; dos Santos, Wagner Farias; McCluskey, Stuart; Wijeysundera, Duminda; Pazmino-Canizares, Janeth; Parotto, Matteo; Wasowicz, Marcin; Beattie, Scott; Meineri, Massimiliano; Clarke, Hance; Ladha, Karim; Jerath, Angela; Ayach, Nour; Poonawala, Humara; Sellers, Daniel; Duncan, Dallas; Carroll, Jo; Hudson, Chris; van Vlymen, Janet; Jaeger, Melanie; Shelley, Jessica; Shore, Debbie DuMerton; McQuaide, Sheila; Richebe, Philipe; Godin, Nadia; Gobert, Quentin; Fortier, Louis Philippe; Verdonck, Oliver; Sato, Hiroaki; Schricker, Thomas; Codere-Maruyama, Takumi; Lattermann, Ralph; Hatzakorzian, Roupen; Moore, Albert; Sato, Tamaki; Funk, Duane; Kowalski, Stephen; Girling, Linda; Monterola, Marita; Fidler, Kelsi; Sander, Michael; Markmann, Melanie; Schulte, Dagmar; Singer, Rabea; Koch, Christian; Ruhrmann, Sophie; Habig, Lukas; Edinger, Fabien; Schneck, Emmanuel; Treskatsch, Sascha; Ertmer, Martin; Trauzeddel, Ralf-Felix; Weyland, Andreas; Diers, Anja; Grote, Thomas; Pabel, Svenja; Lipka, Alien; Nannen, Luhas; Fleischer, Andreas; Wittmann, Maria; Winkler, Anja; Neumann, Claudia; Fingerhut, Marie-Louise; Ehrentraut, Heidi; Guttenthaler, Vera; Heringlake, Matthias; Brandt, Sebastian; Olsson, Silke; Schmidt, Christian; Schemke, Simon; Murat, Lennart; Abu Khudair, Hussein; Farhoud, Esam; Ghidan, Ahmad; Al Masri, Mahmoud; Abu Kwiak, Sameer; Abdel-Nabi, Helen; Grigoras, Ioana; Ristescu, Irina; Jitaru, Iulia; Manole, Madalin; Rusu, Daniel; Gata, Angelica; Aldecoa, Cesar; Gonzalez, Alba Perez; Al
Publication year: 2019
Journal: BMJ Open
Volume number: 9
Issue number: 1
ISSN: 2044-6055
Open access status: Gold
DOI Link: https://doi.org/10.1136/bmjopen-2018-023455
Publisher: BMJ Publishing Group
Introduction Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice. Methods The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1: 1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide. Ethics/dissemination The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication
Abstract:
Citation Styles
Harvard Citation style: Edwards, M., Forbes, G., MacDonald, N., Berdunov, V., Mihaylova, B., Dias, P., et al. (2019) Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery, BMJ Open, 9(1), Article e023455. https://doi.org/10.1136/bmjopen-2018-023455
APA Citation style: Edwards, M., Forbes, G., MacDonald, N., Berdunov, V., Mihaylova, B., Dias, P., Thomson, A., Grocott, M., Mythen, M., Gillies, M., Sander, M., Phan, T., Evered, L., Wijeysundera, D., McCluskey, S., Aldecoa, C., Ripolles-Melchor, J., Hofer, C., Abukhudair, H., ...Al (2019). Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery. BMJ Open. 9(1), Article e023455. https://doi.org/10.1136/bmjopen-2018-023455
Keywords
hemodynamic therapy
