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

IntroductionPostoperative 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 su...

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Published in:	BMJ open Vol. 9; no. 1; p. e023455
Main Authors:	Edwards, Mark R, Forbes, Gordon, MacDonald, Neil, Berdunov, Vladislav, Mihaylova, Borislava, Dias, Priyanthi, Thomson, Ann, Grocott, Michael PW, Mythen, Monty G, Gillies, Mike A, Sander, Michael, Phan, Tuong D, Evered, Lisbeth, Wijeysundera, Duminda N, McCluskey, Stuart A, Aldecoa, Cesar, Ripollés-Melchor, Javier, Hofer, Christoph K, Abukhudair, Hussein, Szczeklik, Wojciech, Grigoras, Ioana, Hajjar, Ludhmila A, Kahan, Brennan C, Pearse, Rupert M
Format:	Journal Article
Language:	English
Published:	England BMJ Publishing Group LTD 01-01-2019 BMJ Publishing Group
Subjects:	Aged Anaesthesia Cardiotonic Agents - administration & dosage Clinical medicine Digestive System Surgical Procedures - methods Female Fentanyl Fluid Therapy Gastrointestinal surgery Hemodynamics Hospitals Humans Hypotheses Informed consent Infusions, Intravenous Intervention Kidneys Male Mortality Multicenter Studies as Topic Narcotics Nosocomial infections Obesity Patients Physiology Postoperative Complications - prevention & control Randomized Controlled Trials as Topic Surgical outcomes hemodynamics/physiology elective surgical procedures/adverse effects intraoperative/methods prospective studies
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Summary:	IntroductionPostoperative 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.MethodsThe 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/disseminationThe 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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2018-023455