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

Critical Care

Adrian Grant⁶  Jennifer Addison³  David Alcorn⁴  Seonaidh C Cotton³  Daniela Rae³  Jonathan Cook³  Julie Brittenden⁷  John Kinsella¹  John Norrie³  Dwayne Boyers⁵  Rodolfo Hernández⁵  Andrew Elders³  Stephen A Stott²  Marion K Campbell³  Brian H Cuthbertson³ 

[1] Section of Anaesthesia Pain and Critical Care, University of Glasgow, 4th Floor, Walton Building, Glasgow Royal Infirmary, 91 Wishart Street, Glasgow, G31 2HT, UK;Intensive Care Unit, Aberdeen Royal Infirmary, Westburn Road, Aberdeen, AB25 2ZN, UK;Health Services Research Unit, Health Sciences Building, University of Aberdeen, Ashgrove Road, Foresterhill, Aberdeen, AB25 2ZD, UK;Royal Alexandra Hospital, Corsebar Road, Paisley, Strathclyde, PA2 9PN, UK;Health Economics Research Unit, Polwarth Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK;Institute of Applied Health Sciences, Health Sciences Building, University of Aberdeen, King's College, Foresterhill, Aberdeen, AB24 3FX, UK;Department of Surgery, University of Aberdeen, Polwarth Building, Foresterhill Aberdeen, AB25 2ZD, UK

关键词: optimisation;    morbidity;    outcome;    fluid therapy;    peri-operative management;    surgery;   

Others  :  1093273
DOI  :  10.1186/cc10592

 received in 2011-06-10, accepted in 2011-12-16,  发布年份 2011

【 摘 要 】

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

【 授权许可】

   
2011 Cuthbertson et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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