Clinical trial NCT06080178: Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
Official title: Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypotension During Surgery
Keywords: arterial hypotension
postoperative hypotension
Goal-directed Fluid Therapy
DIEP free flap breast reconstruction
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A monocentric, prospective, non-inferiority, randomised controlled trial. Interventional, phase IV trial. Patients will be randomly assigned to either a static intraoperative fluid management (reflecting the current standard of care), with a limitation of 5ml/kg/h crystalloids from induction of anaesthesia to completed skin closure, or a dynamic goal-directed fluid management, where crystalloid fluids are only administered during surgery if PPV is above 12%.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Total intraoperative fluid volume
timeFrame: From anaesthesia induction until completed skin closure, assessed up to 12 hours
Secondary outcomes:
measure: Cumulative perioperative fluid volume
timeFrame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
measure: Cumulative perioperative norepinephrine dose
timeFrame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
measure: Peri- and postoperative blood lactate levels
timeFrame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
measure: Percentage of time Systolic Blood Pressure (SBP) was above 100mmHg
timeFrame: During surgery, from anaesthesia induction until completed skin closure, assessed up to 12 hours
measure: Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry)
timeFrame: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours
measure: Surgical complications
timeFrame: At ICU/ PACU discharge, assessed up to 60 hours and at hospital discharge, assessed up to 2 weeks
measure: Length of stay
timeFrame: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
state: East Flanders
Study officials:
affiliation: AZ Maria Middelares Gent
name: Silvie Allaert, MD
role: PRINCIPAL_INVESTIGATOR
References: