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

ConditionHypotension During Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorAlgemeen Ziekenhuis Maria Middelares

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female adult patients, between 18 and 70 years of age

Patients scheduled for DIEP free flap breast reconstruction

Signed written informed consent form (ICF)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Static groupActive comparator 2 interventions
Group B: Dynamic groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Total intraoperative fluid volume

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

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

Secondary outcomes

1

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))

Time frame
From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
2

Cumulative perioperative norepinephrine dose

Cumulative perioperative norepinephrine dose (intraoperative and postoperative norepinephrine dose)

Time frame
From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
3

Peri- and postoperative blood lactate levels

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

Time frame
From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
4

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

Percentage of time SBP was above 100mmHg during surgery

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Algemeen Ziekenhuis Maria Middelares

Lead sponsor

Source ClinicalTrials.gov
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