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Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery.A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery.We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice.Trial registration number - ISRCTN32188676.

Original publication

DOI

10.1186/1745-6215-11-41

Type

Journal article

Journal

Trials

Publication Date

16/04/2010

Volume

11

Addresses

Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. brian.cuthbertson@sunnybrook.ca

Keywords

FOCCUS Study Group, Abdomen, Humans, Treatment Outcome, Fluid Therapy, Critical Care, Preoperative Care, Thoracic Surgical Procedures, Risk Assessment, Prospective Studies, Research Design, Time Factors, Adult, Cost-Benefit Analysis, Hospital Costs, Elective Surgical Procedures, United Kingdom