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.
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.


CONCLUSIONS
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.


BACKGROUND
Trial registration number - ISRCTN32188676.
Cuthbertson
Brian H
BH
Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. brian.cuthbertson@sunnybrook.ca
Campbell
Marion K
MK
Stott
Stephen A
SA
Vale
Luke
L
Norrie
John
J
Kinsella
John
J
Cook
Jonathan
J
Brittenden
Julie
J
Grant
Adrian
A
D000005:Abdomen / Q000601:surgery*; D000328:Adult; D003362:Cost-Benefit Analysis; D003422:Critical Care / Q000191:economics; D017558:Elective Surgical Procedures; D005440:Fluid Therapy / Q000191:economics; D017721:Hospital Costs; D006801:Humans; D011300:Preoperative Care; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D019616:Thoracic Surgical Procedures / Q000009:adverse effects* / Q000191:economics / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
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