Actively Recruiting

Phase 4
Age: 18Years - 70Years
FEMALE
ID06080178

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

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

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)

Post-operative Follow-up

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

Follow-up Assessments

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

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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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