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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.
- Source :
-
Trials [Trials] 2010 Apr 16; Vol. 11, pp. 41. Date of Electronic Publication: 2010 Apr 16. - Publication Year :
- 2010
-
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.<br />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.<br />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.<br />Trial Registration: Trial registration number - ISRCTN32188676.
- Subjects :
- Adult
Cost-Benefit Analysis
Elective Surgical Procedures
Hospital Costs
Humans
Preoperative Care
Prospective Studies
Research Design
Risk Assessment
Thoracic Surgical Procedures economics
Thoracic Surgical Procedures mortality
Time Factors
Treatment Outcome
United Kingdom
Abdomen surgery
Critical Care economics
Fluid Therapy economics
Thoracic Surgical Procedures adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 11
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 20398378
- Full Text :
- https://doi.org/10.1186/1745-6215-11-41