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

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.

Perioperative interventions for prevention of postoperative pulmonary complications: systematic review and meta-analysis

“…A recently published multicentre RCT from Spain (FEDORA,138 published subsequently to our search dates and therefore not included in the meta-analysis) of goal directed haemodynamic therapy versus standard care in patients at lower risk undergoing major surgery showed a statistically significant reduction in PPCs (and other complications) and reduced length of hospital stay. The benefits were exclusively seen in patients having abdominal surgery, and this is relevant as the ongoing OPTIMISE-II study is exclusively recruiting patients undergoing major gastrointestinal surgery 139…”

“…Several large trials that are in progress, or soon to start, will add to our understanding of the role of perioperative goal directed haemodynamic therapy, continuous positive airway pressure, and inspiratory muscle training 139154155. Although it is challenging, trialists should attempt to use standardised endpoints (for both efficacy and adverse effects) and consider aspects relating to the cost and acceptability of interventions.…”

Goal‐directed fluid therapy during major abdominal surgery

“…88 This causes some authors to call for more large-scale studies, while others start to wonder whether traditional science will ever find an answer to this question and recommend starting spending resources on making adequate care reliably available, instead of "chasing ever-decreasing marginal gains." 89 90 Several large clinical trials on GDFT, such as FLO-ELA (using several devices) (www.floela.org) and Optimise II (using FloTrac or Clearsight) 91 are ongoing.…”

Efficacy of Goal-Directed Fluid Therapy Monitored by Pulse-Pressure Variation Using a C ontinuous Non-Invasive Arterial Pressure Monitoring System (the CNAPTM System) During Parathyroidectomy in Patients with End-Stage Renal Failure - A randomized trial

“…There are no guidelines concerning perioperative fluid therapy for patients with end-stage renal failure (ESRF) [1]. Nearly all the studies of perioperative fluid therapy excluded patients with ESRF because of their physical condition [1][2][3][4][5][6][7][8][9][10].…”