Abdominal and thoraco-abdominal surgery Surgery Abdominal and thoraco-abdominal surgery
Conditions
Interventions
Initial randomisation is to pre-operative fluid therapy or standard regimen:
1. Pre-operative fluid therapy - patients will be electively commenced on pre-operative fluid therapy (25 ml/kg) using Hart
Sponsors
University of Aberdeen (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Undergoing major elective and urgent abdominal and thoraco-abdominal surgery 2. Fulfil high-risk surgical criteria 3. Have signed informed consent
Exclusion criteria
Exclusion criteria: 1. New York Heart Association grade IV heart failure 2. Clinician concern 3. Emergency surgery 4. Chronic renal failure/creatinine greater than 200 umol/L 5. Lack of informed consent 6. Aged less than 16 years 7. Pregnancy 8. Major hepatic surgery, expected survival less than six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. For the comparison of level of care (ICU versus HDU): cost-effectiveness at six months, measured by participant completed questionnaires and primary and secondary care costs 2. For the comparison of fluid optimisation: number of hospital days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health status at one month after surgery measured using participant completed survey 2. Quality of life at 48 hours, three and six months after surgery measured using participant completed surgery 3. Changes in health status and quality of life six months after surgery 4. Health care costs, including full hospital costs and primary care costs, in the six months post surgery 5. Mortality and morbidity - mortality using time-to-event analysis 6. Incidence of major morbidities in hospital using Post-Operative Morbidity Score | — |
Countries
United Kingdom
Outcome results
None listed