Clinical trial

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

Name

MMS.2023.036

Description

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.

Trial arms

Trial start

2023-11-23

Estimated PCD

2026-10-01

Trial end

2026-10-01

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Static group

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).

Arms:

Static group

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.

Arms:

Dynamic group

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.

Arms:

Dynamic group

Size

Primary endpoint

Total intraoperative fluid volume

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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%.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 82, 'type': 'ESTIMATED'}}

Updated at

2024-01-17

1 organization

2 products

1 indication

Organization

Algemeen Ziekenhuis Maria Middelares

Product

Plasma-lyte

Indication

Hypotension during surgery

Product

Norepinephrine