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

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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 languageEnglish
Article number41
JournalTrials
Volume11
DOIs
Publication statusPublished - 16 Apr 2010

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