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

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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

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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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