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

January 27, 2025 updated by: Silvie Allaert, Algemeen Ziekenhuis Maria Middelares

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Static group

When during surgery systolic blood pressure (SBP) is below 100mmHg:

  • give a fluid bolus (Plasmalyte A) until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 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).

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

When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min: the anaesthetist can decide to give a bolus of 6mg ephedrine intravenous (IV) (with a maximum dose of 12mg ephedrine iv per hour).
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).
Experimental: Dynamic group

After insertion of an arterial line, a pulse contour analysis system will be installed (Acumen IQ sensor, Edwards) for measuring PPV and cardiac index (CI).

When during surgery SBP is below 100mmHg and PPV is above 12%:

• give a fluid bolus (Plasmalyte A) until PPV is below or equal to 12% or SBP is above 100mmHg

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.

When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min, and CI is < 2.2 L/min/m², a bolus of 6mg ephedrine iv will be given (with a maximum dose of 12mg ephedrine iv per hour).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From anaesthesia induction until completed skin closure, assessed up to 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
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
Cumulative perioperative norepinephrine dose (intraoperative and postoperative norepinephrine dose)
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
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
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
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
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
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
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
ICU/PACU length of stay (LOS) (hours)
From ICU admission until ICU/ PACU discharge, assessed up to 60 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Algemeen Ziekenhuis Maria Middelares

Investigators

  • Principal Investigator: Silvie Allaert, MD, Az Maria Middelares Gent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMS.2023.036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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