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

ISRCTN ISRCTN94850719
DOI https://doi.org/10.1186/ISRCTN94850719
Secondary identifying numbers R&D ref: 004670
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 Bartholomew’s Hospital
London
EC1A 7BE
United Kingdom

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

Study information

Study designRandomised single centre, single blind, study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedMajor abdominal surgery
InterventionIn 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 typeProcedure/Surgery
Primary outcome measureReduction 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 measures1. 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 study start date01/11/2007
Completion date01/12/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants135 (45 per group) (added 23/10/2007)
Key inclusion criteriaAll adult patients admitted to intensive care or high dependency unit following elective major abdominal surgery
Key exclusion criteria1. 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 enrolment01/11/2007
Date of final enrolment01/12/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

5th floor
London
EC1A 7BE
United Kingdom

Sponsor information

Queen Mary's University of London (UK)
University/education

Joint R&D Office
3rd Floor Rutland House
42−46 New Road
Whitechapel
London
E1 2AX
England
United Kingdom

Website http://www.qmul.ac.uk/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Industry

In decreasing order of size:

No information available

Circassia Ltd (UK) - research grant (added 23/10/2007)

No information available

Barts and the London Charity (UK) - research grant (added 23/10/2007)

No information available

Unrestricted educational grant: Zeneus Pharma Ltd (UK)

No information available

Unrestricted educational grant: LiDCO Ltd (UK)

No information available

European Society of Intensive Care Medicine Intelligent Monitoring Award (Europe)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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