Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Plasma-lyte (static group), Norepinephrine (static group), Plasma-lyte (dynamic group), Norepinephrine (dynamic group).
- Who it may be relevant to
- Registry conditions: Hypotension During Surgery. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
Overview
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.
Interventions
- Drug Plasma-lyte (static group)
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 - Drug Norepinephrine (static group)
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). - Drug Plasma-lyte (dynamic group)
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. - Drug Norepinephrine (dynamic group)
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 outcome measures
- Total intraoperative fluid volume [Time frame: From anaesthesia induction until completed skin closure, assessed up to 12 hours]
Secondary outcome measures (7)
- Cumulative perioperative fluid volume [Time frame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours]
- Cumulative perioperative norepinephrine dose [Time frame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours]
- Peri- and postoperative blood lactate levels [Time frame: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours]
- 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]
- Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry) [Time frame: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours]
- Surgical complications [Time frame: At ICU/ PACU discharge, assessed up to 60 hours and at hospital discharge, assessed up to 2 weeks]
- Length of stay [Time frame: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- AZ Maria Middelares — Ghent
Identifiers
NCT: NCT06080178 · MMS.2023.036