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

Recruiting now · Phase 4

Conditions studied: Hypotension During Surgery

In brief

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.

Key facts

Study ID

NCT06080178

Run by

Algemeen Ziekenhuis Maria Middelares

People needed

82

Starts

2023-11-23

Expected to finish

2026-10-01

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female adult patients, between 18 and 70 years of age
• Patients scheduled for DIEP free flap breast reconstruction
• Signed written informed consent form (ICF)

You may not qualify if…

• 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

Where it is running

• AZ Maria Middelares — Ghent, East Flanders, Belgium (enrolling)

Full record on ClinicalTrials.gov

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