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

Cuthbertson, B. H. et al. (2011) A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery - the FOCCUS study. Critical Care, 15, R296. (doi: 10.1186/cc10592) (PMID:22177541) (PMCID:PMC3388651)

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 preoperative 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.

• Item Type: Articles (Other)
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Kinsella, Professor John and Brittenden, Professor Julie and Norrie, Prof John
• Authors: Cuthbertson, B. H., 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.
• Subjects: R Medicine > R Medicine (General)
• College/School: College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Research Group: FOCCUS study group
• Journal Name: Critical Care
• Publisher: BioMed Central
• ISSN: 1364-8535
• ISSN (Online): 1466-609X
• Copyright Holders: Copyright © 2012 Cuthbertson et al.
• First Published: First published in Critical Care 15: R296
• Publisher Policy: Reproduced under a Creative Commons License