Physiological effects of goal directed therapy (incorportating dopexamine infusion) in patients undergoing major surgery

ISRCTN	ISRCTN94850719
DOI	https://doi.org/10.1186/ISRCTN94850719
Protocol serial number	R&D ref: 004670
Sponsor	Queen Mary's University of London (UK)
Funders	In decreasing order of size:, Circassia Ltd (UK) - research grant (added 23/10/2007), Barts and the London Charity (UK) - research grant (added 23/10/2007), Unrestricted educational grant: Zeneus Pharma Ltd (UK), Unrestricted educational grant: LiDCO Ltd (UK), European Society of Intensive Care Medicine Intelligent Monitoring Award (Europe)

Submission date: 04/10/2006
Registration date: 29/01/2007
Last edited: 12/08/2010

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 Rupert Pearse
Scientific

5th floor
38 Little Britain
St Bartholomews Hospital
London
EC1A 7BE
United Kingdom

Phone	+44 (0)20 7601 7526
Email	rupert.pearse@bartsandthelondon.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised single centre, single blind, study.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Approved by the London Multi-Centre Research Ethics Committee on the 17th November 2006 (ref: 06/MRE02/70).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	135
Key inclusion criteria	All adult patients admitted to intensive care or high dependency unit following elective major abdominal surgery
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

5th floor

London
EC1A 7BE
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	01/01/2010		Yes	No