Fluid management strategies during DIEP flap breast reconstruction
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
This study is testing two different ways of managing fluids during DIEP flap breast reconstruction surgery to see which method helps with recovery and flap health better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Algemeen Ziekenhuis Maria Middelares Academic / other |
| Locations | 1 site (Ghent, East Flanders) |
| Trial ID | NCT06080178 on ClinicalTrials.gov |
What this trial studies
This study compares two fluid management strategies during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery to maintain adequate blood pressure and minimize flap oedema. One group will receive a static fluid management approach, limiting fluid administration, while the other will use a dynamic approach guided by Pulse Pressure Variation (PPV) measurements. The goal is to evaluate the impact of these strategies on flap perfusion and postoperative outcomes. Patients will be randomized into two groups to assess the effectiveness of each method.
Who should consider this trial
Good fit: Ideal candidates are female adults aged 18 to 70 scheduled for DIEP free flap breast reconstruction.
Not a fit: Patients with significant heart conditions, chronic kidney disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing DIEP flap breast reconstruction.
How similar studies have performed: Other studies have shown promising results with goal-directed fluid therapy in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ghent, East Flanders
- AZ Maria Middelares — Ghent, East Flanders, Belgium (Recruiting)
Study contacts
- Principal investigator: Silvie Allaert, MD — AZ Maria Middelares Gent
- Study coordinator: Silvie Allaert, MD
- Email: silvie.allaert@mijnziekenhuis.be
- Phone: +32 9 246 17 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.