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BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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: 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

Keywords

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