Contact information
Type
Scientific
Primary contact
Dr Rupert Pearse
ORCID ID
Contact details
5th floor
38 Little Britain
St Bartholomews Hospital
London
EC1A 7BE
United Kingdom
+44 (0)20 7601 7526
rupert.pearse@bartsandthelondon.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R&D ref: 004670
Study information
Scientific title
Acronym
Study hypothesis
To assess whether post-operative Goal Directed Therapy results in improved clinical outcomes through enhanced tissue perfusion and oxygenation.
Please note that as of 23/10/2007 this application was amended. The amendment will allow us to compare the effects on tissue perfusion and oxygenation of post-operative Goal Directed Therapy with intravenous fluid alone and that of Goal Directed Therapy with fluid plus dopexamine. All changes relating to these amendments will be noted under the date '23/10/2007'. These amendments have included the addition of two funders, a change to the target number of participants (as of 17/04/2007 this was updated to 80, and was originally entered as 120), a change to the anticipated start date (this was originally 01/12/2006) and an addition to the interventions.
Ethics approval
Approved by the London Multi-Centre Research Ethics Committee on the 17th November 2006 (ref: 06/MRE02/70).
Study design
Randomised single centre, single blind, study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Major abdominal surgery
Intervention
In addition to maintenance fluid, control group patients will receive additional 250 ml fluid challenges with colloid solution as required, to achieve a sustained rise in central venous pressure.
In addition to maintenance fluid, intervention group patients will receive additional 250 ml fluid challenges with colloid solution as required, to achieve a sustained rise in stroke volume. Patients in the intervention group will also receive dopexamine at a fixed rate of 0.5 mcg/kg/min.
As of 17/04/2007:
Due to funding problems we will only be able to recruit enough patients for our secondary outcome measure therefore only 80 participants are expected to be recruited.
As of 23/10/2007:
A second intervention group will receive, in addition to maintenance fluid, additional 250 ml fluid challenges with colloid solution as required, to achieve a sustained rise in stroke volume but this will not be supplemented with dopexamine.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Reduction in post-operative complication rates associated with the use of Goal Directed Therapy.
Added as of 23/10/2007:
Increase in tissue oxygenation associated with the use of Goal Directed Therapy.
Secondary outcome measures
1. Reduction in microvascular perfusion associated with the use of Goal Directed Therapy
2. Reduction in tissue oxygenation associated with the use of Goal Directed Therapy
3. Reduction in post-operative duration of hospital stay associated with the use of Goal Directed Therapy
4. Reduction in post-operative mortality associated with the use of Goal Directed Therapy
Overall trial start date
01/11/2007
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All adult patients admitted to intensive care or high dependency unit following elective major abdominal surgery
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
135 (45 per group) (added 23/10/2007)
Participant exclusion criteria
1. Refusal of consent
2. Concurrent lithium therapy
3. Acute myocardial ischaemia
4. Acute arrhythmias
5. Pregnancy
6. Patients receiving palliative treatment only
7. Weight less than 40 kg
Recruitment start date
01/11/2007
Recruitment end date
01/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
5th floor
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Queen Mary's University of London (UK)
Sponsor details
Joint R&D Office
3rd Floor Rutland House
42−46 New Road
Whitechapel
London
E1 2AX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
In decreasing order of size:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Circassia Ltd (UK) - research grant (added 23/10/2007)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Barts and the London Charity (UK) - research grant (added 23/10/2007)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Unrestricted educational grant: Zeneus Pharma Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Unrestricted educational grant: LiDCO Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Society of Intensive Care Medicine Intelligent Monitoring Award (Europe)
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20698956
Publication citations
-
Results
Jhanji S, Vivian-Smith A, Lucena-Amaro S, Watson D, Hinds CJ, Pearse RM, Haemodynamic optimisation improves tissue microvascular flow and oxygenation after major surgery: a randomised controlled trial., Crit Care, 2010, 14, 4, R151, doi: 10.1186/cc9220.