Actively Recruiting
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2025-01-28
82
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two fluid management strategies during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery to maintain adequate blood pressure and reduce the risk of flap swelling (oedema). This trial compares a static fluid strategy with limited crystalloid fluid administration to a dynamic strategy guided by Pulse Pressure Variation (PPV), a measurement of preload dependency. The goal is to see which method better supports flap perfusion and reduces complications related to fluid overload during surgery. Participants are randomly assigned to one of two groups. The static group receives crystalloid fluids limited to 5 ml/kg/h, with norepinephrine given if blood pressure remains low. The dynamic group receives fluids only if PPV exceeds 12%, with norepinephrine used when PPV is low but blood pressure is below target. During surgery, blood pressure and PPV are continuously monitored with sensors. After surgery, sensors are applied to monitor flap perfusion in the Intensive Care or recovery unit. Throughout the study, researchers track fluid volumes administered during and after surgery, norepinephrine doses, blood lactate levels, and blood pressure stability. They also assess tissue oxygenation and blood flow of the flap, monitor surgical complications, and record length of stay in recovery. These measurements help determine how each fluid strategy affects flap health and patient recovery over the course of surgery and the following days.
CONDITIONS
Brief Title
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 hours
Participants undergo Deep Inferior Epigastric Perforator (DIEP) free flap breast reconstruction surgery with either static or dynamic fluid therapy strategies to maintain blood pressure and optimize flap perfusion.
1 surgical visit (in-person)
Duration - Up to 72 hours
Participants are monitored in the Intensive Care Unit or Post-Anesthesia Care Unit with sensors to assess flap perfusion and tissue oxygenation, and receive care including fluid and vasopressor management.
Continuous monitoring during ICU/PACU stay
Duration - Up to 2 weeks
Participants are assessed for surgical complications and recovery progress up to 2 weeks after surgery.
1 to 2 visits depending on recovery
Trial Site Locations
Total: 1 location
1
AZ Maria Middelares
Ghent, East Flanders, Belgium, 9000
Actively Recruiting
Research Team
S
Silvie Allaert, MD
E
Ella Hermie, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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