Statistical Methods for Contemporary Clinical Trials
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,
Edwards MR, Forbes G, Walker N, Morton DG, Mythen MG, Murray D, Anderson I, Mihaylova B, Thomson A, Taylor M, Hollyman M, Phillips R, Young K, Kahan BC, Pearse RM, Grocott MPW for the FLO-ELA investigators
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. In this paper, authors demonstrate application of the estimand framework to clearly define the treatment effect estimate for the primary outcome.