No registrations found.
ID
Source
Health condition
Dobutamine, microcirculation, DIEP-flap, Laser Doppler
Sponsors and support
Intervention
Outcome measures
Primary outcome
increase in blood flow (PU, measured by means of laser doppler)
Secondary outcome
- flap necrosis
- fat necrosis
- amount of escape medication used
- quality of life
Background summary
Since dobutamine in low doses exerts both a vasodilatory as an inotropic effect, infusion during free flap surgery is suggested to increase the arterial flow and hence decrease the complication rate. With this trial we want to investigate whether dobutamine infusion increases the flow in free flap surgery, and consequently decreases the complication rate in a double-blind placebo controlled intervention study.
Study objective
Does intravenous infusion of low doses dobutamine solely peroperative or for 18 more hours postoperative in women undergoing a breast reconstruction by menas of a DIEP flap, increase the blood flow in arterioles after dobutamine infusion as compared to placebo (NaCl 0.9% infusion) measured by means of laser doppler
Study design
- baseline
- peroperative
- postoperative (first day, 2 weeks, 6 weeks and 3 months)
Intervention
- dobutamine peroperative, 18 hours post-operative placebo
- dobutamine peroperative and 18 hours post-operative
- placebo both per- and postoperative
dr. H. van der Hoffplein 1
L. Solberg,
Sittard 6162 BG
The Netherlands
06-50829183
solberglaura@gmail.com.
dr. H. van der Hoffplein 1
L. Solberg,
Sittard 6162 BG
The Netherlands
06-50829183
solberglaura@gmail.com.
Inclusion criteria
- women
- age between 30 and 65 years old
- breast carcinoma in the history
- mastectomy in the history
- planned secondary reconstruction by means of a DIEP-flap
Exclusion criteria
- cardiac history (specifically atrial fibrillation and/or cardiac ischemia)
- clotting disorders (deep venous thrombosis or pulmonary embolus in the medical history)
- smoking
- known allergy for dobutamine and/or bisulfite
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4043 |
| NTR-old | NTR4209 |
| CCMO | NL42897.096.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38526 |