+1 877 705 1914• 24 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 4
Age: 18Years - 70Years
FEMALE
ID06080178

Comparing Fluid Management Strategies Using Pulse Pressure Variation to Improve Outcomes in DIEP Free Flap Breast Reconstruction Surgery

Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2025-01-28

82

Participants Needed

1

Research Sites

N/A

Total Duration

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 mlkgh, 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

Research Team

S

Silvie Allaert, MD

E

Ella Hermie, MSc

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here