A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery - the FOCCUS study

Brian H. Cuthbertson*, Marion K. Campbell, Stephen A. Stott, Andrew Elders, Rodolfo Hernández, Dwayne Boyers, John Norrie, John Kinsella, Julie Brittenden, Jonathan Cook, Daniela Rae, Seonaidh C. Cotton, David Alcorn, Jennifer Addison, Adrian Grant

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery.Methods: This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome.Results: A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective.Conclusions: Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care.Trial registration: Prospective Clinical Trials, ISRCTN32188676.

Original languageEnglish
Article numberR296
JournalCritical Care
Volume15
Issue number6
DOIs
Publication statusPublished - 16 Dec 2011

Keywords

  • Fluid therapy
  • Morbidity
  • Optimisation
  • Outcome
  • Peri-operative management
  • Surgery

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