Dataset Information

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.

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.

SUBMITTER: Edwards MR

PROVIDER: S-EPMC6341180 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

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.

Edwards Mark R MR Forbes Gordon G MacDonald Neil N Berdunov Vladislav V Mihaylova Borislava B Dias Priyanthi P Thomson Ann A Grocott Michael Pw MP Mythen Monty G MG Gillies Mike A MA Sander Michael M Phan Tuong D TD Evered Lisbeth L Wijeysundera Duminda N DN McCluskey Stuart A SA Aldecoa Cesar C Ripollés-Melchor Javier J Hofer Christoph K CK Abukhudair Hussein H Szczeklik Wojciech W Grigoras Ioana I Hajjar Ludhmila A LA Kahan Brennan C BC Pearse Rupert M RM

BMJ open 20190115 1

<h4>Introduction</h4>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 ...[more]

PMID: 30647034

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