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| [ ...Back to search results ] | [ Print-friendly version ] |
| Physiological effects of goal directed therapy (incorportating dopexamine infusion) in patients undergoing major surgery |
| ISRCTN | ISRCTN94850719 |
| ClinicalTrials.gov identifier | |
| Public title | Physiological effects of goal directed therapy (incorportating dopexamine infusion) in patients undergoing major surgery |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | R&D ref: 004670 |
| 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. |
| Lay summary | |
| 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. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Major abdominal surgery |
| Participants - inclusion criteria | All adult patients admitted to intensive care or high dependency unit following elective major abdominal surgery |
| Participants - 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 |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 01/12/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 135 (45 per group) (added 23/10/2007) |
| Interventions |
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. |
| 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. |
| 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 |
| Sources of funding |
In decreasing order of size:
1. Circassia Ltd (UK) - research grant (added 23/10/2007) 2. Barts and the London Charity (UK) - research grant (added 23/10/2007) 3. Unrestricted educational grant: Zeneus Pharma Ltd (UK) 4. Unrestricted educational grant: LiDCO Ltd (UK) 5. European Society of Intensive Care Medicine Intelligent Monitoring Award (Europe) |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20698956 |
| Contact name | Dr Rupert Pearse |
| Address |
5th floor
38 Little Britain St Bartholomew’s Hospital |
| City/town | London |
| Zip/Postcode | EC1A 7BE |
| Country | United Kingdom |
| Tel | +44 (0)20 7601 7526 |
| Fax | +44 (0)20 7601 7526 |
| rupert.pearse@bartsandthelondon.nhs.uk | |
| Sponsor | Queen Mary's University of London (UK) |
| Address |
Joint R&D Office
3rd Floor Rutland House 42−46 New Road Whitechapel |
| City/town | London |
| Zip/Postcode | E1 2AX |
| Country | United Kingdom |
| Sponsor website: | http://www.qmul.ac.uk/ |
| Date applied | 04/10/2006 |
| Last edited | 12/08/2010 |
| Date ISRCTN assigned | 29/01/2007 |
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