Clinical Trial

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

Study acronym: GDFT DIEP-flap
Recruiting Phase 4
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-10; most recent amendment 2025-01-27.
Status change: Not Yet Recruiting → Recruiting 2024-01-12
Trial Details
NCT Number NCT06080178
Lead Sponsor Algemeen Ziekenhuis Maria Middelares
Conditions Hypotension During Surgery
Enrollment 82 participants
Start Date 2023-11-23
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-28