RecruitingPhase 4NCT06080178

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

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

Sponsor

Algemeen Ziekenhuis Maria Middelares

Enrollment

82 participants

Start Date

Nov 23, 2023

Study Type

INTERVENTIONAL

Conditions

Hypotension During Surgery

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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 Criteria8

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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Interventions

DRUGPlasma-lyte (static group)

Plasmalyte will be administered intravenously: (1) as a maintenance infusion 1ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg

DRUGNorepinephrine (static group)

When during surgery SBP is below 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).

DRUGPlasma-lyte (dynamic group)

Plasmalyte will be administered intravenously: (1) as a maintenance infusion 1 ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until PPV is below or equal to 12% or SBP is above 100mmHg.

DRUGNorepinephrine (dynamic group)

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.