FOCCUS: Pragmatic multi-centre randomised trial of (1) routing postoperative ICU care and/or (2) pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery and urgent surgery
In Scotland about 4,500 patients die each year around the time of surgery. Because of a lack of critical care facilities, patients usually receive post-operative care in either the general surgical ward environment or a ward-based surgical high-dependency unit (HDU). This study was an economic evaluation as part of a multicentre randomised trial to evaluate both the roles of (a) high-dependency care versus intensive care in the post-operative period after high-risk major surgery and (b) pre-operative fluid loading, using a 2*2 factorial design.
Due to a lack of availability of intensive care unit beds, recruitment to the first comparison was postponed and the study focused instead on the straightforward comparison of fluid loading using 25ml/kg of Ringer’s lactate solution with no routine fluid loading in the management of high-risk surgery-elective surgical patients in Scotland.
The study found that a pragmatic fluid-loading intervention consisting of Ringer’s lactate solution delivered in the hours prior to major elective surgery could be achieved with an intervention cost of £51 per case. Adjusting for baseline variables, the fluid loading group was on average £2,047 less costly (95% CI: -£6,947 to £2,854) and more effective [mean 0.043 QALYs (95%CI:-0.017 to 0.103)] than routine care. Fluid loading had an 89% probability of being cost-effective at a willingness-to-pay per QALY threshold of £30,000. Sensitivity analyses did not alter the overall conclusions.
Outcome and Translation
The results suggest that the intervention has a high probability of cost-effectiveness compared with a standard-of-care approach with no routine fluid loading. Further, larger studies are required to confirm these results. If the results of this study are confirmed in a definitive RCT, this intervention may be easily introduced into routine care with a potential for cost savings in the allocation of scarce NHS resources.
External collaborators: B Cuthbertson (Sunnybrook Health Services Centre, Toronto); M Campbell, J Norrie, A Grant (HSRU, University of Aberdeen); S Stott (ICU, Aberdeen Royal Infirmary); L Vale (University of Newcastle); J Brittenden (Vascular Surgery, Aberdeen Royal Infirmary); J Kinsella (Anaesthesia, University of Glasgow).
Cuthbertson, B., Campbell, M., Stott, S., Vale, L., Norrie, N., Kinsella, J., Cook, J., Brittenden, J., Grant, A. and the FOCCUS Study Group (2010) ‘Pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol,’ Trials, 11, 41.
Cuthbertson, B., Stott, S., Campbell, M., Vale, L., Cook, J., Norrie, J., Brittenden, J., Kinsella, J., Grant, A., Alcorn, D., Serpell, M., McColl, A., Rae, D., Shepherd, K., Addison, J., McPherson, G., McDonald, A., Cotton, S., Elders, A., MacLennan, G., Boyers, D. and Hernández, R. Pragmatic multi-centre randomised trial of (1) routine postoperative ICU care and/or (2) pre-operative fluid loading in high-risk surgical patients undergoing major elective and urgent surgery. Final report submitted to CSO. April 2010.
Cuthbertson, B.C., Campbell, M.K., Stott, S.A., Elders, A., Hernández, R., Boyers, D., Norrie, J., Kinsella, J., Brittenden, J., Cook, J., Rae, D., Cotton, S.C., Alcorn, D., Addison, J. and Grant, A. on behalf of the FOCCUS Study Group. (2011) ‘Pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: FOCCUS study,’ Critical Care. 15(6), R296.
Boyers, D., Hernández, R., Vale, L., Elders, A. and Cuthbertson, B. (2011) 'Pragmatic multi-centre randomised trial of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery: a cost effectiveness analysis', Health Technology Assessment international (HTAi), Rio de Janeiro, Brazil, June 2011.
Boyers, D., Hernández, R., Vale, L., Elders, A. and Cuthbertson, B.H. (2014) 'The value of future research to determine the cost-effectiveness of fluid loading prior to high risk major elective surgery: the use of expected value of sample information', Society for Medical Decision Making, 15th Biennial European Meeting, Special Focus on Clinical Decision Making in the Era of Personalized Medicine, Antwerp, Belgium, 8–10 June 2014.