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Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction

RecruitingPhase 4Ages 18 Years - 70 YearsFemaleAlgemeen Ziekenhuis Maria Middelares
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In plain words

What the trial is, and whether it could suit you

Adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery requires maintaining blood pressure above 100 mmHg and avoiding excessive fluid administration. This study aims to determine whether the use of a measurement of preload dependency (Pulse Pressure Variation = PPV), can guide fluid therapy and if it decreases the risk of flap oedema. For this purpose, two fluid management strategies will be compared: * Static intraoperative fluid management: Administration of crystalloid fluids is limited to 5ml/kg/h * Dynamic intraoperative fluid management: Crystalloid fluids are only administered if PPV exceeds 12% The purpose of this study is to compare the static and dynamic (= targeted) fluid strategy and to evaluate the effect on flap oedema and flap perfusion.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female adult patients, between 18 and 70 years of age * Patients scheduled for DIEP free flap breast reconstruction * Signed written informed consent form (ICF) Exclusion Criteria: * present atrial fibrillation (AF) * heart failure New York Heart Association (NYHA) classification 2 or higher * chronic kidney disease (CKD) stage 3B or higher * American Society of Anesthesiologists (ASA) classification III or higher * known allergy to study specific medication * participation in another clinical trial * Inability of the patient to understand Dutch sufficiently * Patients who are pregnant or breastfeeding
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What it tests

  • Plasma-lyte (static group)
  • Norepinephrine (static group)
  • Plasma-lyte (dynamic group)
  • Norepinephrine (dynamic group)
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Where

1 site
AZ Maria Middelares
Ghent, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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