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, B.H., Campbell, M.K., Stott, S.A., Vale, L., Norrie, J., Kinsella, J., Cook, J., Brittenden, J. and Grant, A. (2010) 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. Trials, 11, p. 41. (doi: 10.1186/1745-6215-11-41)

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.

• Item Type: Articles (Other)
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Norrie, Prof John and Kinsella, Professor John
• Authors: Cuthbertson, B.H., Campbell, M.K., Stott, S.A., Vale, L., Norrie, J., Kinsella, J., Cook, J., Brittenden, J., and Grant, A.
• Subjects: R Medicine > RD Surgery
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; ?? 20206000 ??; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Clinical Specialities
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN (Online): 1745-6215
• Published Online: 16 April 2010
• Copyright Holders: Copyright © 2010 The Authors
• First Published: First published in Trials 11:41
• Publisher Policy: Reproduced in accordance with the copyright policy of the publisher