A pragmatic multi-centre randomised controlled evaluation of level of dependency and pre-operative fluid loading in high-risk surgical patients undergoing major elective and urgent surgery
| ISRCTN | ISRCTN32188676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32188676 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/07/2007
- Registration date
- 30/08/2007
- Last edited
- 01/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Brian Cuthbertson
Scientific
Scientific
3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| Phone | +44 (0)1224 552730 |
|---|---|
| b.h.cuthbertson@abdn.ac.uk |
Study information
| Study design | Multicentre, prospective, randomised, controlled trial with a partial 2 x 2 factorial design. The term partial recognises that some patients might not be recruited to the HDU versus ICU comparison. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | FOCCUS |
| Study objectives | Whether: 1. Ward-based pre-operative fluid loading, and/or 2. Routine post-operative care in an Intensive Care Unit (ICU), improve outcome in high-risk surgical patients undergoing major elective and urgent surgery, and are effective and cost-effective. |
| Ethics approval(s) | Ethics approval received from the Multi Centre Research Ethics Committee for Scotland on the 21st March 2005 (ref: 04/MRE10/76). On 10th April 2007 the Committee Co-ordinator confirmed that the start date of 17th August 2007 is acceptable. |
| Health condition(s) or problem(s) studied | Abdominal and thoraco-abdominal surgery |
| Intervention | 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 Hartmanns solution over six hours before surgery in the ward 2. Standard fluid regimen - No routine pre-operative fluid therapy The second randomisation is to routine ICU or High Dependency Unit (HDU) for post-operative care: 1. ICU care - Initial post-operative care undertaken in the ICU under the care of ICU clinicians 2. HDU care - Initial post-operative care undertaken in a surgical HDU under the care of the surgical team Due to a possible lack of availability of ICU beds, we anticipate randomising approximately 174 of the participants to the second stage. The expectation is that trial participants will remain in ICU or HDU according to their allocation for at least 48 hours after surgery unless a clear clinical reason for a change develops. All participants will be followed up for one week for major morbidity and mortality, then at one, three and six months after surgery for survival and quality of life. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 17/08/2007 |
| Completion date | 16/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 204 participants to the first randomisation comparing fluid optimisation. |
| Key inclusion criteria | 1. Undergoing major elective and urgent abdominal and thoraco-abdominal surgery 2. Fulfil high-risk surgical criteria 3. Have signed informed consent |
| Key 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 |
| Date of first enrolment | 17/08/2007 |
| Date of final enrolment | 16/07/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
3rd Floor
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
University Office
Kings College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk/R&I |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/392)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/04/2010 | Yes | No | |
| Results article | results | 01/04/2011 | Yes | No |
