Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery

for the FLO-ELA investigators, Gordon Forbes, Rachel Phillips, Anna Clark, Michael Carter, James Green, Jack Lee, Rachel Olive, John Harris, Christopher Ward, Laura Adams, Thomas Hansen, Claire Potter, Julia Sampson, Peter Sutton, Rachel Smith, Christopher Smith, Sue Smith, Stephen Harris, Tahir AliDavid Jones, Sarah Cooper, James Morgan, Kariem El-Boghdadly, Paul Kelly, Charlotte Taylor, Nicole Richards, Robert Jackson, Louise White, Jignesh Patel, Matthew Smith, Maria Fernandez, Sarah Todd, James Harvey, Dave Robinson, Anna Morris, Louise Duncan, Sarah Clark, Hannah Wilson, Sarah Evans, Richard Mason, Eleanor Corcoran, James Bland, Gudrun Kunst, Helen Murray, Sinéad Kelly, Emily Johnson, Pooja Takhar, Laura Jones, Alastair Duncan, David Evans, Matthew Butler, Anna Simpson, Robert Thompson, Paul Jackson, Leanne Smith, James Graham

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Introduction: Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice. Methods: The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication. Discussion: This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias. Trial registration: ISRCTN 14729158. Registered on 02 May 2017.

Original languageEnglish
Article number313
JournalTrials
Volume24
Issue number1
Early online date6 May 2023
DOIs
Publication statusPublished - Dec 2023

Keywords

  • Emergency surgical procedures/adverse effects
  • Hemodynamics/physiology
  • Intraoperative/methods
  • Postoperative complications/prevention and control
  • Prospective studies

Cite this