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The influence of dobutamine on the microcirculation in the DIEP-flap


- candidate number15555
- NTR NumberNTR4209
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-okt-2013
- Secondary IDsNL42897.096.13 
- Public TitleThe influence of dobutamine on the microcirculation in the DIEP-flap
- Scientific TitleThe effect of peroperative intravenous dobutamine on the microcirculatory perfusion of the DIEP-flap
- ACRONYM
- hypothesisDoes 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
- Healt Condition(s) or Problem(s) studiedMicrocirculation, Dobutamine, Diep-flap
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2013
- planned closingdate1-mei-2015
- Target number of participants60
- Interventions- dobutamine peroperative, 18 hours post-operative placebo

- dobutamine peroperative and 18 hours post-operative

- placebo both per- and postoperative
- Primary outcomeincrease in blood flow (PU, measured by means of laser doppler)
- Secondary outcome- flap necrosis
- fat necrosis
- amount of escape medication used
- quality of life
- Timepoints- baseline
- peroperative
- postoperative (first day, 2 weeks, 6 weeks and 3 months)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdrs. L. Solberg,
- CONTACT for SCIENTIFIC QUERIESDr R.R.W.J. Hulst, van der
- Sponsor/Initiator Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
Orbis Medisch Centrum
- PublicationsN/A
- Brief summarySince 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.
- Main changes (audit trail)
- RECORD15-okt-2013 - 2-dec-2013


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