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
Protocol serial number	N/A
Sponsor	University of Aberdeen (UK)
Funder	Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/392)

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

3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Phone	+44 (0)1224 552730
Email	b.h.cuthbertson@abdn.ac.uk

Study information

Primary study design	Interventional
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.
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	16/07/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	204
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

United Kingdom
Scotland

Study participating centre

3rd Floor

Aberdeen
AB25 2ZD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011		Yes	No
Protocol article	protocol	16/04/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes