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Study on Fluid Therapy and Noradrenaline for Low Blood Pressure in Breast Reconstruction Surgery Patients

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying arterial hypotension, which is a condition where blood pressure is lower than normal, during a specific type of breast reconstruction surgery known as deep inferior epigastric perforator (DIEP) free flap surgery. The study will explore the effects of a treatment approach called goal-directed fluid therapy, which involves carefully managing the fluids given to patients during surgery to maintain optimal blood pressure and fluid balance.

Two treatments will be used in this study. The first is a solution called Plasma-Lyte® 148 (pH 7.4) solution for infusion, which contains a mix of important salts and minerals like magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, and sodium gluconate. These substances help maintain the body's fluid and electrolyte balance. The second treatment is a medication called noradrenaline (norepinephrine) 1 mg/ml concentrate for solution for infusion, which is used to help increase blood pressure by narrowing blood vessels.

The purpose of the study is to investigate how this fluid management strategy affects the amount of fluid given during surgery and its impact on the patient's recovery. Participants will receive either the treatment or a placebo during their surgery. The study will monitor various factors, such as the total amount of fluid given during surgery, the amount of noradrenaline used, and the patient's blood pressure and recovery in the intensive care unit. The study aims to provide valuable insights into improving care for patients undergoing DIEP free flap breast reconstruction.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing a written informed consent form.

    Eligibility includes being a female adult between 18 and 70 years of age, scheduled for DIEP free flap breast reconstruction.

  2. Step 2

    Preparation for surgery

    Before surgery, preparations are made for the procedure, which involves deep inferior epigastric perforator (DIEP) free flap breast reconstruction.

  3. Step 3

    Surgery and fluid management

    During surgery, a solution called Plasma-Lyte® 148 is administered through an intravenous infusion to manage fluid levels.

    The goal is to control fluid administration effectively throughout the operation.

  4. Step 4

    Use of norepinephrine

    If necessary, norepinephrine is given intravenously to manage blood pressure during and after surgery.

    The dosage is adjusted based on the patient's needs to maintain stable blood pressure.

  5. Step 5

    Postoperative monitoring

    After surgery, monitoring continues in the intensive care unit (ICU) or post-anesthesia care unit (PACU).

    Blood lactate levels are checked hourly during surgery and every four hours in the ICU until discharge.

    The percentage of time the systolic blood pressure (SBP) is above 100mmHg is recorded.

  6. Step 6

    Free flap perfusion monitoring

    Postoperative free flap perfusion is monitored using near-infrared spectroscopy (NIRS) during the ICU/PACU stay.

  7. Step 7

    Assessment of surgical outcomes

    Surgical complications, such as flap loss or hematoma, are assessed at ICU/PACU discharge and at hospital discharge.

  8. Step 8

    Discharge and follow-up

    The length of stay in the ICU/PACU is recorded in hours.

    Discharge from the hospital occurs after ensuring stable recovery and monitoring results.

Who can join the trial?

3 criteria

  • Female adult patients, between 18 and 70 years of age
  • Patients scheduled for **DIEP free flap breast reconstruction** (a type of surgery to rebuild the breast using tissue from the lower belly)
  • Signed written **informed consent form** (a document that explains the study and confirms the patient's agreement to participate)

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing arterial hypotension during the specific type of breast reconstruction surgery called DIEP free flap. Arterial hypotension means having low blood pressure in the arteries.
  • Patients who are not within the specified age range for the study.
  • Patients who are not female, as the study is only for female participants.
  • Patients who belong to a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

Goal-directed Fluid Therapy is a method used to manage the amount of fluids given to a patient during surgery. In this trial, it is being used during breast reconstruction surgery to ensure that the patient receives the right amount of fluids. This approach aims to improve the patient's recovery by optimizing fluid levels, which can help maintain blood pressure and reduce complications.

What is already known about the treatment

Phenylephrine – Phenylephrine is typically administered intravenously and is used to manage low blood pressure, particularly during surgical procedures like deep inferior epigastric perforator (DIEP) free flap breast reconstruction. It is well-documented in medical literature as a vasopressor, which means it helps increase blood pressure by constricting blood vessels. The main therapeutic indication for phenylephrine is to treat hypotension, especially in surgical settings. At the molecular level, phenylephrine works by stimulating alpha-1 adrenergic receptors, leading to vasoconstriction and increased blood pressure. It is classified pharmacologically as a sympathomimetic agent.

Investigated diseases

Arterial Hypotension during Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction – This condition involves a drop in blood pressure that occurs during a specific type of breast reconstruction surgery known as DIEP free flap. The procedure uses tissue from the lower abdomen to reconstruct the breast, and maintaining stable blood pressure is crucial for the success of the surgery. Arterial hypotension can lead to inadequate blood flow to the transplanted tissue, potentially affecting its viability. The condition is managed by carefully monitoring and adjusting fluid levels and medications during the operation. It is important to ensure that blood pressure remains within a safe range to support the healing process. This condition is not classified as a rare disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506152-24-00Estimated enrolment82 patientsSponsorAz Maria Middelares Gent

sourced from the EU Clinical Trials Register and site verification

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