Hypotension During SurgeryPhase 4GDFT DIEP-flapNCT06080178
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
A Phase 4 study testing Plasma-lyte (static group), Norepinephrine (static group) and Plasma-lyte (dynamic group) in people with Hypotension During Surgery, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Plasma-lyte (static group), Norepinephrine (static group) and Plasma-lyte (dynamic group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Nov 2023to 13 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female adult patients, between 18 and 70 years of age
- Patients scheduled for DIEP free flap breast reconstruction
- Signed written informed consent form (ICF)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypotension During Surgery
- Being tested
- Plasma-lyte (static group), Norepinephrine (static group), Plasma-lyte (dynamic group), Norepinephrine (dynamic group)
- Keywords
- arterial hypotension, postoperative hypotension, Goal-directed Fluid Therapy, DIEP free flap breast reconstruction
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Plasma-lyte (dynamic group); Drug: Norepinephrine (dynamic group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative fluid volume
Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)
Measured: From anaesthesia induction until completed skin closure, assessed up to 12 hours
Secondary outcomes (7)
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))
Measured: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
Cumulative perioperative norepinephrine dose
Cumulative perioperative norepinephrine dose (intraoperative and postoperative norepinephrine dose)
Measured: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
Peri- and postoperative blood lactate levels
Peri- and postoperative blood lactate levels (hourly measurement during surgery, every four hours in the ICU until discharge)
Measured: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours
Percentage of time Systolic Blood Pressure (SBP) was above 100mmHg
Percentage of time SBP was above 100mmHg during surgery
Measured: During surgery, from anaesthesia induction until completed skin closure, assessed up to 12 hours
Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry)
Postoperative free flap perfusion monitored by near-infrared spectroscopy (NIRS) during ICU/PACU stay
Measured: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours
Surgical complications
Surgical complications (e.g. total or partial flap loss, venous flap congestion, hematoma) assessed at ICU/PACU discharge and at hospital discharge
Measured: At ICU/ PACU discharge, assessed up to 60 hours and at hospital discharge, assessed up to 2 weeks
Length of stay
ICU/PACU length of stay (LOS) (hours)
Measured: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start23 Nov 2023
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Why it stopped: The planned interim analysis revealed greater variability than expected, requiring a larger sample size. Given the limited eligible population, recruitment was deemed infeasible within a reasonable timeframe, leading to study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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%.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvie Allaert, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Silvie Allaert, MD, Principal investigator, AZ Maria Middelares Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080178
- Sponsor's protocol ID
- MMS.2023.036
- Acronym
- GDFT DIEP-flap
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06080178
- Acronym / sponsor ID
- GDFT DIEP-flap / MMS.2023.036
- Conditions
- Hypotension During Surgery
- Keywords
- arterial hypotension, postoperative hypotension, Goal-directed Fluid Therapy, DIEP free flap breast reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The planned interim analysis revealed greater variability than expected, requiring a larger sample size. Given the limited eligible population, recruitment was deemed infeasible within a reasonable timeframe, leading to study termination.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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%.
| Arm | Type | Receives |
|---|---|---|
| Static group | Active comparator | Drug: Plasma-lyte (static group), Drug: Norepinephrine (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). |
| Dynamic group | Experimental | Drug: Plasma-lyte (dynamic group), Drug: Norepinephrine (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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female adult patients, between 18 and 70 years of age
- Patients scheduled for DIEP free flap breast reconstruction
- Signed written informed consent form (ICF)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Static group |
| 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). | Drug | Static group |
| 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 | Dynamic group |
| 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. | Drug | Dynamic group |
Primary outcome
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)
7 secondary outcomes
Cumulative perioperative fluid volume
Time frame: 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
Peri- and postoperative blood lactate levels
Time frame: 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
Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry)
Time frame: 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
Length of stay
Time frame: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours
Results and safety
The study was stopped early (reason given: The planned interim analysis revealed greater variability than expected, requiring a larger sample size. Given the limited eligible population, recruitment was deemed infeasible within a reasonable timeframe, leading to study termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvie Allaert, MD principal investigator
AZ Maria Middelares Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasma-lyte (static group), Norepinephrine (static group) and Plasma-lyte (dynamic group) in people with Hypotension During Surgery, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The planned interim analysis revealed greater variability than expected, requiring a larger sample size. Given the limited eligible population, recruitment was deemed infeasible within a reasonable timeframe, leading to study termination.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative fluid volume (time frame: From anaesthesia induction until completed skin closure, assessed up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.