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NCT Number: NCT06080178

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

AZ Maria Middelares

Ghent, East Flanders, 9000, Belgium

Location status: Recruiting

Location contact

Steffi Ryckaert, MSc

CONTACT

[email protected]

00322461708

About this study

For adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery, blood pressure must remain sufficiently high. General anaesthesia often induces systemic hypotension. To counteract this hypotension, the anaesthetist administers intravenous fluids (crystalloid fluids). However, fluid overload can lead to an increased risk of flap oedema and decreased flap perfusion and in exceptional cases to flap failure. To maintain blood pressure above 100 mmHg and to avoid excessive fluid administration, a vasopressor (norepinephrine) can be administered. This reduces the amount of fluids administered, thereby reducing the risk of flap oedema.

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. To this end, 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.

All included patients are randomized in a 1:1 ratio to the static (n = 41) or dynamic group (n = 41).

To treat hypotension in patients randomized to the 'static' group, fluid administration is limited to 5 ml/kg/h. When the maximum fluid volume is administered but blood pressure remains below 100 mmHg, norepinephrine is administered.

Treatment of hypotension in patients randomized to the 'dynamic' (= targeted fluid therapy) group, is guided by PPV. PPV is measured continuously during the surgery and if the blood pressure is below 100 mmHg, fluids are only administered if PPV is > 12%. If blood pressure is below 100 mmHg but PPV is < 12% (indicating no fluid is needed), norepinephrine is administered.

At the end of the procedure, 2 sensors are applied, these sensors provide information about the perfusion of the free flap during patient's stay in Intensive Care or the recovery room.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma-lyte (static group)

Drug

Plasmalyte will be administered intravenously: (1) as a maintenance infusion 1ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg

Norepinephrine (static group)

Drug

When during surgery SBP is below 100mmHg, if the 5ml/kg/h crystalloid limit is already reached, start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min).

Plasma-lyte (dynamic group)

Drug

Plasmalyte will be administered intravenously:

(1) as a maintenance infusion 1 ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until PPV is below or equal to 12% or SBP is above 100mmHg.

Norepinephrine (dynamic group)

Drug

When during surgery SBP is below 100mmHg and PPV is below or equal to 12%: start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min).

When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.

Primary outcomes

  1. Total intraoperative fluid volume

    Time frame: From anaesthesia induction until completed skin closure, assessed up to 12 hours

    Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)

Secondary outcomes

  1. Cumulative perioperative fluid volume

    Time frame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours

    Cumulative perioperative fluid volume (intraoperative fluid volume + fluid administered in the intensive care unit (ICU) or post-anaesthesia care unit (PACU))

  2. Cumulative perioperative norepinephrine dose

    Time frame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours

    Cumulative perioperative norepinephrine dose (intraoperative and postoperative norepinephrine dose)

  3. Peri- and postoperative blood lactate levels

    Time frame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours

    Peri- and postoperative blood lactate levels (hourly measurement during surgery, every four hours in the ICU until discharge)

  4. Percentage of time Systolic Blood Pressure (SBP) was above 100mmHg

    Time frame: During surgery, from anaesthesia induction until completed skin closure, assessed up to 12 hours

    Percentage of time SBP was above 100mmHg during surgery

  5. Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry)

    Time frame: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours

    Postoperative free flap perfusion monitored by near-infrared spectroscopy (NIRS) during ICU/PACU stay

  6. Surgical complications

    Time frame: At ICU/ PACU discharge, assessed up to 60 hours and at hospital discharge, assessed up to 2 weeks

    Surgical complications (e.g. total or partial flap loss, venous flap congestion, hematoma) assessed at ICU/PACU discharge and at hospital discharge

  7. Length of stay

    Time frame: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours

    ICU/PACU length of stay (LOS) (hours)

Study contacts

Contact information is provided by the study sponsor or research team.

Ella Hermie, MSc

CONTACT

[email protected]

+32 9 246 17 03

Silvie Allaert, MD

CONTACT

[email protected]

+32 9 246 17 00

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

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

Acronym: GDFT DIEP-flap

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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