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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

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
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
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 in a widely accessible peer-reviewed scientific journal.

Trial registration number: ISRCTN39653756.
2044-6055
Edwards, Mark
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Forbes, Gordon
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MacDonald, Neil
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Berdunov, Vladislav
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Mihaylova, Borislava
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Dias, Priyanthi
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Thomson, Ann
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Grocott, Michael
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Mythen, Monty G.
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Gillies, Mike
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Sander, Michael
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Phan, Tuong D.
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Evered, Lis
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Wijeysundera, Duminda N.
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McCluskey, Stuart A.
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Aldecoa, Cesar
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Ripolles- Melchor, Javier
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Hofer, Christopoh K.
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Abukhudair, Hussein
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Szczeklik, Wojciech
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Grigoras, Ioana
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Hajjar, Ludhmila A.
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Kahan, Brennan C.
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Pearse, Rupert M.
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Edwards, Mark
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Forbes, Gordon
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MacDonald, Neil
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Berdunov, Vladislav
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Mihaylova, Borislava
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Dias, Priyanthi
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Thomson, Ann
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Grocott, Michael
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Mythen, Monty G.
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Gillies, Mike
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Sander, Michael
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Phan, Tuong D.
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Evered, Lis
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Wijeysundera, Duminda N.
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McCluskey, Stuart A.
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Aldecoa, Cesar
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Ripolles- Melchor, Javier
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Hofer, Christopoh K.
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Abukhudair, Hussein
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Szczeklik, Wojciech
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Grigoras, Ioana
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Hajjar, Ludhmila A.
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Kahan, Brennan C.
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Pearse, Rupert M.
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Edwards, Mark, Forbes, Gordon, MacDonald, Neil, Berdunov, Vladislav, Mihaylova, Borislava, Dias, Priyanthi, Thomson, Ann, Grocott, Michael, Mythen, Monty G., Gillies, Mike, Sander, Michael, Phan, Tuong D., Evered, Lis, Wijeysundera, Duminda N., McCluskey, Stuart A., Aldecoa, Cesar, Ripolles- Melchor, Javier, Hofer, Christopoh K., Abukhudair, Hussein, Szczeklik, Wojciech, Grigoras, Ioana, Hajjar, Ludhmila A., Kahan, Brennan C. and Pearse, Rupert M. (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. (doi:10.1136/bmjopen-2018-023455).

Record type: Article

Abstract

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 in a widely accessible peer-reviewed scientific journal.

Trial registration number: ISRCTN39653756.

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Edwards BMJ Open 2019 OPTIMISE 2 methdods paper - Version of Record
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Accepted/In Press date: 10 October 2018
e-pub ahead of print date: 15 January 2019

Identifiers

Local EPrints ID: 428002
URI: https://eprints.soton.ac.uk/id/eprint/428002
ISSN: 2044-6055
PURE UUID: 1addb36e-675a-491f-9aeb-467ca699ea19

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Date deposited: 06 Feb 2019 17:30
Last modified: 14 Aug 2019 16:35

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Contributors

Author: Mark Edwards
Author: Gordon Forbes
Author: Neil MacDonald
Author: Vladislav Berdunov
Author: Borislava Mihaylova
Author: Priyanthi Dias
Author: Ann Thomson
Author: Michael Grocott
Author: Monty G. Mythen
Author: Mike Gillies
Author: Michael Sander
Author: Tuong D. Phan
Author: Lis Evered
Author: Duminda N. Wijeysundera
Author: Stuart A. McCluskey
Author: Cesar Aldecoa
Author: Javier Ripolles- Melchor
Author: Christopoh K. Hofer
Author: Hussein Abukhudair
Author: Wojciech Szczeklik
Author: Ioana Grigoras
Author: Ludhmila A. Hajjar
Author: Brennan C. Kahan
Author: Rupert M. Pearse

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