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. 2019 Jan 15;9(1):e023455.
doi: 10.1136/bmjopen-2018-023455.

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

Mark R Edwards  1   2 , Gordon Forbes  3 , Neil MacDonald  4 , Vladislav Berdunov  3 , Borislava Mihaylova  5 , Priyanthi Dias  6 , Ann Thomson  3 , Michael Pw Grocott  1   2 , Monty G Mythen  7 , Mike A Gillies  8 , Michael Sander  9 , Tuong D Phan  10 , Lisbeth Evered  10 , Duminda N Wijeysundera  11 , Stuart A McCluskey  11 , Cesar Aldecoa  12 , Javier Ripollés-Melchor  13 , Christoph K Hofer  14 , Hussein Abukhudair  15 , Wojciech Szczeklik  16 , Ioana Grigoras  17 , Ludhmila A Hajjar  18 , Brennan C Kahan  3 , Rupert M Pearse  6 ; OPTIMISE II investigators
Collaborators, Affiliations

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

Mark R Edwards et al. BMJ Open. .

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.

Keywords: elective surgical procedures/adverse effects; hemodynamics/physiology; intraoperative/methods; prospective studies.

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Conflict of interest statement

Competing interests: MRE has received an honorarium for lecturing for Edwards Lifesciences and is Chief Investigator of the NIHR-funded FLO-ELA trial of cardiac output-guided haemodynamic therapy in patients undergoing emergency abdominal surgery. MPWG reports serving as Medical Advisory Board, Sphere Medical Ltd; Director, EBPOM Social Enterprise; Director, Oxygen Control Systems Ltd; Director, EBPOM USA. UK NIHR CRN National Specialty Lead for Anaesthesia, Perioperative Medicine and Pain. Joint Editor-in-Chief, Perioperative Medicine. MGM reports personal fees from Deltex Medical, personal fees from Edwards Lifesciences, personal fees from Baxter, grants from Smiths Medical, outside the submitted work. In addition, MGM has a patent ’QUENCH' (clinical hydration solutions limited) a patient hydration device (issued). MS reports grants from Edwards Lifesciences, during the conduct of the study; grants from Medtronic, grants from AMOMED, grants from Edwards Lifesciences, grants from Gettinge Group, outside the submitted work. TDP reports grants from Australian and New Zealand College of Anaesthetists, during the conduct of the study. LE reports personal fees from Cogstate, outside the submitted work. DAM reports personal fees from Edwards Lifesciences, outside the submitted work. JR-M reports personal fees from Edwards Lifesciences, during the conduct of the study; personal fees and non-financial support from Edwards Lifesciences, from Fresenius Kabi, from Deltex Medical, outside the submitted work. RMP holds research grants, and has given lectures and/or performed consultancy work for Nestle Health Sciences, BBraun, Medtronic, Glaxo Smithkline, Intersurgical, and Edwards Lifesciences, and is a member of the Associate editorial board of the British Journal of Anaesthesia. RMP is supported in part by an NIHR Professorship. The OPTIMISE II trial is adopted by the UK Perioperative Medicine Clinical Trials Network. DNW is supported in part by a New Investigator Award from the Canadian Institutes of Health Research and a Merit Award from the Department of Anesthesia at the University of Toronto.

Figures

Figure 1
Figure 1
Algorithm for cardiac output-guided haemodynamic therapy for participants in the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II intervention group.
See this image and copyright information in PMC

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