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Trials. 2010 Apr 16;11:41. doi: 10.1186/1745-6215-11-41.

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.

Author information

1
Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. brian.cuthbertson@sunnybrook.ca

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.

PMID:
20398378
PMCID:
PMC2873273
DOI:
10.1186/1745-6215-11-41
[Indexed for MEDLINE]
Free PMC Article

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