Condition category
Surgery
Date applied
02/07/2007
Date assigned
30/08/2007
Last edited
01/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.charttrials.abdn.ac.uk/foccus/

Contact information

Type

Scientific

Primary contact

Dr Brian Cuthbertson

ORCID ID

Contact details

3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 552730
b.h.cuthbertson@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

FOCCUS

Study hypothesis

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

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.

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

17/08/2007

Overall trial end date

16/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Undergoing major elective and urgent abdominal and thoraco-abdominal surgery
2. Fulfil high-risk surgical criteria
3. Have signed informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

204 participants to the first randomisation comparing fluid optimisation.

Participant 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

Recruitment start date

17/08/2007

Recruitment end date

16/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

3rd Floor
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

University Office
Kings College
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

University/education

Website

http://www.abdn.ac.uk/R&I

Funders

Funder type

Government

Funder name

Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/392)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20398378
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22177541

Publication citations

  1. Protocol

    Cuthbertson BH, Campbell MK, Stott SA, Vale L, Norrie J, Kinsella J, Cook J, Brittenden J, Grant A, , 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., Trials, 2010, 11, 41, doi: 10.1186/1745-6215-11-41.

  2. Results

    Cuthbertson BH, Campbell MK, Stott SA, Elders A, Hernández R, Boyers D, Norrie J, Kinsella J, Brittenden J, Cook J, Rae D, Cotton SC, Alcorn D, Addison J, Grant A, , A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study., Crit Care, 2011, 15, 6, R296, doi: 10.1186/cc10592.

Additional files

Editorial Notes