title: A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  Prospective Clinical Trials, ISRCTN32188676.
authors.affiliation: Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Room D132, Toronto, ON M4N 3M5, Canada. Brian.Cuthbertson@sunnybrook.ca
authors.forename: Brian H
authors.initials: BH
authors.lastname: Cuthbertson
authors.forename: Marion K
authors.initials: MK
authors.lastname: Campbell
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Stott
authors.forename: Andrew
authors.initials: A
authors.lastname: Elders
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Hernández
authors.forename: Dwayne
authors.initials: D
authors.lastname: Boyers
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.forename: John
authors.initials: J
authors.lastname: Kinsella
authors.forename: Julie
authors.initials: J
authors.lastname: Brittenden
authors.forename: Jonathan
authors.initials: J
authors.lastname: Cook
authors.forename: Daniela
authors.initials: D
authors.lastname: Rae
authors.forename: Seonaidh C
authors.initials: SC
authors.lastname: Cotton
authors.forename: David
authors.initials: D
authors.lastname: Alcorn
authors.forename: Jennifer
authors.initials: J
authors.lastname: Addison
authors.forename: Adrian
authors.initials: A
authors.lastname: Grant
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D017558:Elective Surgical Procedures / Q000191:economics / Q000379:methods*; D005260:Female; D005440:Fluid Therapy / Q000191:economics / Q000379:methods*; D006801:Humans; D007552:Isotonic Solutions / Q000191:economics / Q000627:therapeutic use; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care / Q000191:economics / Q000379:methods*; D000077331:Ringer's Solution; D016896:Treatment Outcome
chemical_list: D007552:Isotonic Solutions; D000077331:Ringer's Solution