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 Cuthbertson, Marion Kay Campbell, S.a. Stott, Luke David Vale, John David Norrie, John Kinsella, Jonathan Alistair Cook, Julie Brittenden, Adrian Maxwell Grant, Foccus Study Group

Research output: Contribution to journalArticle

5 Citations (Scopus)
4 Downloads (Pure)

Abstract

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: 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 number- ISRCTN32188676.
Original languageEnglish
Number of pages7
JournalTrials
Volume11
Issue number41
DOIs
Publication statusPublished - 16 Apr 2010

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Clinical Protocols
Randomized Controlled Trials
Fluid Therapy
Random Allocation
Morbidity
Critical Care
Ambulatory Surgical Procedures
Cost-Benefit Analysis
Mortality

Cite this

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; Campbell, Marion Kay; Stott, S.a.; Vale, Luke David; Norrie, John David; Kinsella, John; Cook, Jonathan Alistair; Brittenden, Julie; Grant, Adrian Maxwell; Foccus Study Group.

In: Trials, Vol. 11, No. 41, 16.04.2010.

Research output: Contribution to journalArticle

Cuthbertson, Brian ; Campbell, Marion Kay ; Stott, S.a. ; Vale, Luke David ; Norrie, John David ; Kinsella, John ; Cook, Jonathan Alistair ; Brittenden, Julie ; Grant, Adrian Maxwell ; Foccus Study Group. / 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. In: Trials. 2010 ; Vol. 11, No. 41.
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AU - Vale, Luke David

AU - Norrie, John David

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AU - Cook, Jonathan Alistair

AU - Brittenden, Julie

AU - Grant, Adrian Maxwell

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AB - 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: 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 number- ISRCTN32188676.

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