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

Hypotension During Surgery Clinical Trial

— GDFT DIEP-flap  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080178
• Other study ID #: MMS.2023.036
• Status: Recruiting
• Phase: Phase 4
• Start date: November 23, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: January 2024
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Silvie Allaert, MD
• Phone: +32 9 246 17 00
• Email: silvie.allaert[@]mijnziekenhuis.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Surgery

Intervention

Drug:
• Plasma-lyte
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
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
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
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.

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total intraoperative fluid volume	Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)	From anaesthesia induction until completed skin closure, assessed up to 12 hours
Secondary	Cumulative perioperative fluid volume	Cumulative perioperative fluid volume (intraoperative fluid volume + fluid administered in the intensive care unit (ICU) or post-anaesthesia care unit (PACU))	From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
Secondary	Cumulative perioperative norepinephrine dose	Cumulative perioperative norepinephrine dose (intraoperative and postoperative norepinephrine dose)	From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
Secondary	Peri- and postoperative blood lactate levels	Peri- and postoperative blood lactate levels (hourly measurement during surgery, every four hours in the ICU until discharge)	From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
Secondary	Percentage of time Systolic Blood Pressure (SBP) was above 100mmHg	Percentage of time SBP was above 100mmHg during surgery	During surgery, from anaesthesia induction until completed skin closure, assessed up to 12 hours
Secondary	Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry)	Postoperative free flap perfusion monitored by near-infrared spectroscopy (NIRS) during ICU/PACU stay	From ICU admission until ICU/ PACU discharge, assessed up to 60 hours
Secondary	Surgical complications	Surgical complications (e.g. total or partial flap loss, venous flap congestion, hematoma) assessed at ICU/PACU discharge and at hospital discharge	At ICU/ PACU discharge, assessed up to 60 hours and at hospital discharge, assessed up to 2 weeks
Secondary	Length of stay	ICU/PACU length of stay (LOS) (hours)	From ICU admission until ICU/ PACU discharge, assessed up to 60 hours