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

NCT06080178 | Recruiting Phase 4

• 1 other identifier: MMS.2023.036
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension During Surgery

Keywords

arterial hypotension; postoperative hypotension; Goal-directed Fluid Therapy; DIEP free flap breast reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cumulative perioperative fluid volume

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

• Cumulative perioperative norepinephrine dose

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

• Peri- and postoperative blood lactate levels

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

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

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

• Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry)

  From ICU admission until ICU/ PACU discharge, assessed up to 60 hours

Study Arms (2)

Static group

ACTIVE COMPARATOR

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); Drug: Norepinephrine (static group)

Dynamic group

EXPERIMENTAL

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); Drug: Norepinephrine (dynamic group)

Interventions

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

Static group

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).

Static group

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.

Dynamic group

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.

Dynamic group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female adult patients, between 18 and 70 years of age
• Patients scheduled for DIEP free flap breast reconstruction
• Signed written informed consent form (ICF)

You may not qualify if:

• 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

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, East Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Plasma-lyte 148; Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Silvie Allaert, MD

  AZ Maria Middelares Gent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvie Allaert, MD

CONTACT

+32 9 246 17 00; silvie.allaert@mijnziekenhuis.be

Ella Hermie, MSc

CONTACT

+32 9 246 17 03; ella.hermie@mijnziekenhuis.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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%.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 12, 2023
• Study Start: November 23, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

BE (1)