A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

Cuthbertson, Brian H.; Campbell, Marion K; Stott, S; Vale, Luke; Norrie, John; Kinsella, John; Cook, Jonathan; Brittenden, Julie; Grant, Adrian

doi:10.1186/1745-6215-11-41

Cited by 6 publications

(5 citation statements)

References 11 publications

(15 reference statements)

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“…Although it must be identified that some of this reduction in employment is due to retirements. This change in employment status speaks to the broad long-term financial impact of severe sepsis on patients and their families [ 15 , 18 , 42 ].…”

Section: Discussionmentioning

confidence: 99%

Mortality and quality of life in the five years after severe sepsis

et al. 2013

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IntroductionSevere sepsis is associated with high levels of morbidity and mortality, placing a high burden on healthcare resources. We aimed to study outcomes in the five years after severe sepsis.MethodsThis was a cohort study using data from a prospective audit in 26 adult ICUs in Scotland. Mortality was measured using clinical databases and quality of life using Short Form 36 (SF-36) at 3.5 and 5 years after severe sepsis.ResultsA total of 439 patients were recruited with a 58% mortality at 3.5 years and 61% mortality at 5 years. A total of 85 and 67 patients responded at 3.5 and 5 years follow-up, respectively. SF-36 physical component score (PCS) was low compared to population controls at 3.5 years (mean 41.8 (SD 11.8)) and at 5 years (mean 44.8 (SD 12.7)). SF-36 mental component score (MCS) was slightly lower than population controls at 3.5 years (mean 47.7 (SD 14.6)) and at 5 years after severe sepsis (mean 48.8 (SD 12.6)). The majority of patients were satisfied with their current quality of life (QOL) (80%) and all patients would be willing to be treated in an ICU again if they become critically ill despite many having unpleasant memories (19%) and recall (29%) of ICU events.ConclusionsPatients with severe sepsis have a high ongoing mortality after severe sepsis. They also have a significantly lower physical QOL compared to population norms but mental QOL scores were only slightly below population norms up to five years after severe sepsis. All survivors would be willing to be treated in an ICU again if critically ill. Mortality and QOL outcomes were broadly similar to other critically ill cohorts throughout the five years of follow-up.

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Section: Discussionmentioning

confidence: 99%

Mortality and quality of life in the five years after severe sepsis

et al. 2013

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“…The latter has been a focus of sustained effort in orthopedic circles with a reduction in mortality in hospital after orthopedic admission recorded in recent years by SASM (http://www.sasm.org). Such an approach of optimization has been successful in cardiovascular circles [28] and is in clinical trials for more general surgical procedures [29].…”

Section: Discussionmentioning

confidence: 99%

Mortality Associated with the Treatment of Gallstone Disease: A 10‐Year Contemporary National Experience

et al. 2010

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“…This was a multi-centre, prospective, randomised, controlled trial conducted in four Scottish hospitals, coordinated from the Centre for Healthcare Randomised Trials in the Health Services Research Unit, University of Aberdeen [ 20 ]. The trial was designed as a partial 2*2 factorial design with initial randomisation to fluid loading versus no fluid loading, with a secondary randomisation (if an ICU bed was available at the time of recruitment) to intensive care (level 3) versus high dependency (level 2) care [ 20 ]. The second randomisation had to be abandoned, however, due to a continuing lack of ICU beds at the time of patient recruitment (this decision was agreed upon with the funder, the Data Monitoring Committee (DMC) and the Trial Safety Committee (TSC).…”

Section: Methodsmentioning

confidence: 99%

“…The full power calculation is presented in the trial protocol paper [ 20 ]. For the fluid comparison, we aimed to be able to detect a 0.5 SD difference in the primary outcome of number of days in hospital following surgery, with 80% power and 5% significance.…”

Section: Methodsmentioning

confidence: 99%

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

Cuthbertson

Campbell²,

Stott

et al. 2011

Crit Care

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IntroductionFluid 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.MethodsThis 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.ResultsA 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.ConclusionsPre-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 registrationProspective Clinical Trials, ISRCTN32188676

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A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

Cited by 6 publications

References 11 publications

Mortality and quality of life in the five years after severe sepsis

Mortality and quality of life in the five years after severe sepsis

Mortality Associated with the Treatment of Gallstone Disease: A 10‐Year Contemporary National Experience

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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