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
Scientific
5th floor
38 Little Britain
St Bartholomews Hospital
London
EC1A 7BE
United Kingdom
Phone | +44 (0)20 7601 7526 |
---|---|
rupert.pearse@bartsandthelondon.nhs.uk |
Study information
Study design | Randomised single centre, single blind, study. |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/11/2007 |
Completion date | 01/12/2009 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 135 (45 per group) (added 23/10/2007) |
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
- England
- United Kingdom
Study participating centre
5th floor
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Queen Mary's University of London (UK)
University/education
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/ |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |