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

doi:10.1186/cc10592

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 journal › Article › peer-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 language	English
Article number	R296
Journal	Critical Care
Volume	15
Issue number	6
DOIs	https://doi.org/10.1186/cc10592
Publication status	Published - 16 Dec 2011

Keywords / Materials (for Non-textual outputs)

Fluid therapy
Morbidity
Optimisation
Outcome
Peri-operative management
Surgery

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10.1186/cc10592

Cite this

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., & Grant, A. (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(6), Article R296. https://doi.org/10.1186/cc10592

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

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.",

keywords = "Fluid therapy, Morbidity, Optimisation, Outcome, Peri-operative management, Surgery",

author = "Cuthbertson, \{Brian H.\} and Campbell, \{Marion K.\} and Stott, \{Stephen A.\} and Andrew Elders and Rodolfo Hern{\'a}ndez and Dwayne Boyers and John Norrie and John Kinsella and Julie Brittenden and Jonathan Cook and Daniela Rae and Cotton, \{Seonaidh C.\} and David Alcorn and Jennifer Addison and Adrian Grant",

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doi = "10.1186/cc10592",

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Cuthbertson, BH, Campbell, MK, Stott, SA, Elders, A, Hernández, R, Boyers, D, Norrie, J, Kinsella, J, Brittenden, J, Cook, J, Rae, D, Cotton, SC, Alcorn, D, Addison, J & Grant, A 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, vol. 15, no. 6, R296. https://doi.org/10.1186/cc10592

TY - JOUR

T1 - A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery - the FOCCUS study

AU - Cuthbertson, Brian H.

AU - Campbell, Marion K.

AU - Stott, Stephen A.

AU - Elders, Andrew

AU - Hernández, Rodolfo

AU - Boyers, Dwayne

AU - Norrie, John

AU - Kinsella, John

AU - Brittenden, Julie

AU - Cook, Jonathan

AU - Rae, Daniela

AU - Cotton, Seonaidh C.

AU - Alcorn, David

AU - Addison, Jennifer

AU - Grant, Adrian

PY - 2011/12/16

Y1 - 2011/12/16

N2 - 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.

AB - 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.

KW - Fluid therapy

KW - Morbidity

KW - Optimisation

KW - Outcome

KW - Peri-operative management

KW - Surgery

UR - https://www.scopus.com/pages/publications/83455178690

U2 - 10.1186/cc10592

DO - 10.1186/cc10592

M3 - Article

C2 - 22177541

AN - SCOPUS:83455178690

SN - 1364-8535

VL - 15

JO - Critical Care

JF - Critical Care

IS - 6

M1 - R296

ER -

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

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