Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Female adult patients, between 18 and 70 years of age
• Patients scheduled for DIEP free flap breast reconstruction
• Signed written informed consent form (ICF)
Locations
Other Locations
Belgium
AZ Maria Middelares
RECRUITING
Ghent
Contact Information
Primary
Silvie Allaert, MD
silvie.allaert@mijnziekenhuis.be
+32 9 246 17 00
Backup
Ella Hermie, MSc
ella.hermie@mijnziekenhuis.be
+32 9 246 17 03
Time Frame
Start Date:2023-11-23
Estimated Completion Date:2026-10-01
Participants
Target number of participants:82
Treatments
Active_comparator: Static group
When during surgery systolic blood pressure (SBP) is below 100mmHg:~* give a fluid bolus (Plasmalyte A) until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg~* if the 5ml/kg/h crystalloid limit is already reached: start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min).~When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.~When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min: the anaesthetist can decide to give a bolus of 6mg ephedrine intravenous (IV) (with a maximum dose of 12mg ephedrine iv per hour).
Experimental: Dynamic group
After insertion of an arterial line, a pulse contour analysis system will be installed (Acumen IQ sensor, Edwards) for measuring PPV and cardiac index (CI).~When during surgery SBP is below 100mmHg and PPV is above 12%:~• give a fluid bolus (Plasmalyte A) until PPV is below or equal to 12% or SBP is above 100mmHg~When during surgery SBP is below 100mmHg and PPV is below or equal to 12%:~• start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min) When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.~When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min, and CI is \< 2.2 L/min/m², a bolus of 6mg ephedrine iv will be given (with a maximum dose of 12mg ephedrine iv per hour).